scholarly journals A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of MyVir tablets in mildly symptomatic COVID-19 patients

2021 ◽  
Vol 10 (8) ◽  
pp. 967
Author(s):  
C. R. Jayanthi ◽  
Shankar A. S. ◽  
M. Ravi Shankar ◽  
Lakshmana Perumal S. P. T. ◽  
Manjunath Reddy L. ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Test Group ◽  
Standard Of Care ◽  
Controlled Study ◽  
Control Group ◽  
Immune Markers ◽  
Open Label ◽  
Early Recovery ◽  
Early Improvement ◽  
D Dimer

Background: Coronavirus can cause pneumonia, respiratory failure and death. The emergence of novel coronavirus has posed a challenging situation that warrants urgent global attention. Currently there was no effective therapy available for COVID-19 and hence antiviral and immune modulators are most sought after medicines to manage complications of COVID-19.Methods: In this study involving mild COVID-19 we randomized 42 patients to receive a MyVir tablets twice daily along with standard of care (SOC) or SOC alone in 1:1 ratio for 14 days. We evaluated the benefits of MyVir tablets by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer, TLC).Results: At the end of the study the immune markers in MyVir group improved significantly compared to control group. In patients who received MyVir, CRP decreased from 3.3 mg/l to 1.7 mg/l (p=0.0171). D-dimer decreased from 0.589 on day 0 to 0.368 on day 14 (p=0.03) and LDH decreased from 224 U/l on day 0 to 158 U/l on day 14 in test group (p=0.05). TLC showed favorable improvement in study group compared to control group. Early recovery from COVID-19 symptoms was observed in patients on MyVir treated group. Patients treated with MyVir tablets reduced the duration of hospitalization when given along with standard of care.Conclusions: MyVir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that MyVir tablets has antiviral, immune booster activity. Hence this study provides evidence that MyVir has definitive role in the management of mild COVID-19 patients along with standard of care (funded by Mi Lab Life Sciences(P) Ltd. CTRI no. CTRI/2020/05/024967).

scholarly journals A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of Herbovir syrup in mildly symptomatic COVID-19 patients

2020 ◽  
Vol 10 (1) ◽  
pp. 106
Author(s):  
A. Gopal Rao ◽  
Shankar Achar Somashekar ◽  
Poorna Prasad ◽  
Manjunath Reddy Lekkala ◽  
Sreenivasa Hanumanthaiah ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Standard Of Care ◽  
Pulmonary Complications ◽  
Controlled Study ◽  
Control Group ◽  
P Value ◽  
Immune Markers ◽  
Open Label ◽  
Early Recovery ◽  
D Dimer

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications. Effective antiviral and immune boosters are need of hour to treat COVID-19 as well as post COVID complications.Methods: In this study involving mild COVID-19 we randomized 40 patients to receive a Herbovir syrup along with standard of care (SOC) or SOC alone in 1:1 ratio. We evaluated the benefits of Herbovir syrup by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer).Results: At the end of the study the immune markers in Herbovir group improved significant compared to control group. In patients who received Herbovir, LDH decreased from 334 U/l at baseline to 254 U/l at the end of treatment (p value <0.009), CRP decreased from 7.4 mg/l to 3.1 mg/l (p value=0.0171) and D-dimer decreased from 0.610 mg/l at baseline to 318 mg/l at the end of study (p value=0.001). TLC values did not go below normal range in Herbovir group whereas 8 patients in control group had low TLC at the end of study. Early recovery from COVID 19 symptoms was observed in >75% patients in Herbovir treated group.Conclusions: Herbovir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that Herbovir syrup has antiviral, immune booster activity and has definitive role in the management of mild COVID-19 patients along with standard of care. (Funded by Venkat pharma. CTRI no. CTRI/2020/08/027041).

scholarly journals A prospective, open label clinical study to evaluate the safety, efficacy and tolerability of azadvir herbal steam inhaler in asymptomatic, mildly symptomatic COVID-19 patients and health care workers posted to covid wards

2021 ◽  
Vol 10 (4) ◽  
pp. 373
Author(s):  
Ajitha Pottirayil ◽  
Shankar A. S. ◽  
Shaji Kannoth ◽  
Poorna Prasad ◽  
Sharath Kumar B. Jaikar ◽  
...  
Keyword(s):  
Clinical Symptoms ◽  
Standard Of Care ◽  
P Value ◽  
Rt Pcr ◽  
Immune Markers ◽  
Open Label ◽  
Asymptomatic Group ◽  
Asymptomatic Patients ◽  
Study Results ◽  
D Dimer

Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications even with currently available of standard of care. Additional antiviral and immune boosters are the need of hour to treat COVID-19 and to prevent post covid complications.Methods: In this study we enrolled 40 asymptomatic to mild COVID-19 patients to receive azadvir herbal steam inhaler along with standard of care. We evaluated the benefits of azadvir herbal steam inhaler by assessing RT-PCR conversion, clinical outcomes and improvement in immune markers (LDH, CRP, D-DIMER).Results: At the end of the study the immune markers improved significantly in study patients. In mild symptomatic cases IL-6 was 23.2 pg/ml on day 0 and 21.8 pg/ml on day 14. Reduction in IL-6 in mild symptomatic patients was statistically highly significant (p=0.0056). Mean IL-6 in asymptomatic patients was 22.3 pg/ml on day 0 and 21.1 pg/ml on day 14. Reduction in IL-6 in asymptomatic patients was statistically highly significant (p=0.0035).  Mean D-dimer was showing decreasing trend from day 0 to day 14 in mild symptomatic patients. In asymptomatic patients D dimer was 0.8 µg/ml on day 0 and 0.6 µg/ml on day 14. D-dimer decreased significantly from day 0 to day 14 (p value =0.0013). Mean LDH values on day 0 in mild symptomatic patients was 319.4 U/l and 219.3 on day 14. The reduction in LDH values in mild symptomatic patients is statistically significant (p value <0.0122). In asymptomatic patients mean LDH values on day 0 was 237 U/l and 194 U/l on day 14. The reduction in LDH values in asymptomatic group was statistically significant. Mean CRP values in mild symptomatic patients on day 0 was 12.2 mg/l and 3.8 mg/l on day 14. There was significant reduction in CRP values in mild symptomatic group which was statistically significant (p value =0.0546). Mean CRP values in asymptomatic patients on day 0 was 4.9 mg/l and 2.8 mg/l on day 14. There was significant reduction in mean CRP in asymptomatic patients which was statistically significant (p value =0.0446). In the present study all 40 patients (100%) cleared the virus and became negative for RT PCR test within 6 days. None of the patients progressed to severe COVID-19 and none of the patients succumbed to the disease.Conclusions: Azadvir accelerated recovery of COVID-19 patients by RT-PCR conversion, early improvement in clinical symptoms and immune markers in this study. This study results clearly indicates that azadvir has antiviral, immune booster activity and has definitive role in the management of asymptomatic to mild COVID-19 patients along with standard of care (CTRI no. CTRI/2020/06/026181).

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

2018 ◽  
Vol 16 (2) ◽  
Author(s):  
Ilana Levy ◽  
Samuel Attias ◽  
Lior Cohen ◽  
Nadav Stoppelmann ◽  
Dan Steinberger ◽  
...  
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Analgesic Effect ◽  
Pain Treatment ◽  
Standard Of Care ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Pain Level ◽  
Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

scholarly journals Can 2-Aticyto Complex be an Effective Agent for Recovery of The Symptoms and Enhancing Laboratory Parameters in COVID-19 Patients?

2021 ◽  
Vol 3 (2) ◽  
pp. 35-39
Author(s):  
Ferhan Kerget ◽  
Buğra Kerget ◽  
Alperen Aksakal ◽  
Abdullah Osman Koçak
Keyword(s):  
Clinical Symptoms ◽  
Clinical Course ◽  
Symptomatic Treatment ◽  
Clinical Situation ◽  
National Guideline ◽  
Control Group ◽  
Effective Agent ◽  
Laboratory Parameters ◽  
Taste And Smell ◽  
D Dimer

Background: SARS-CoV-2 (Covid-19) pandemic which was firstly identified in Wuhan/China in December 2019.There still exists no precise treatment for this pandemic yet despite many agents are tried in prophylaxis and treatment for Covid-19. In this study, we aimed to investigate the efficacy of 2-aticyto complex in clinical course in these patients. Materials and Methods: 150 patients who applied to the Infection Diseases Polyclinics between dates September 2020-November 2020 having diagnosed with Covid-19 were included in our study. The patients were randomized into 2 groups (75 in each group) of which the first group only had the treatment of National Guideline and the second group had Viruthol® including 2-aticyto complex (at the dose of 27000 mcg/day) in addition to the treatment of the National Guideline. The laboratory parameters, clinical outcomes and the first day on which PCR result turned into negative of the patients were compared. Results: In Viruthol® group, LDH, CRP, D-Dimer and ferritin levels were significantly decreased compared to the control group, while lymphocyte levels were higher. (p=0.02, p=0.001, p=0.01, p=0.02, p=0,001 respectively).  In addition to that, clinical symptoms such as fever, headache, weakness, loss of taste and smell and muscle-joint pain recovered more rapidly in contrast with the control group (p=0.001, p=0.05, p=0.001, p=0.001, p=0.001, respectively). PCR results of the Viruthol® group turned negative in a statistically significant shorter period of time with respect to the control group (p=0.001). Conclusion: Viruthol® containing 2-aticyto complex may be an agent that can be used both symptomatic treatment and improving the clinical situation and recovery of the patients followed up for Covid-19.

Abstract 2562: Two-Year Clinical Follow-Up of COREA-TAXUS Trial: Long-Term Safety And Efficacy of Celecoxib for 6 Months After Paclitaxel-Eluting Stents Implantation

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Jin-Wook Chung ◽  
Han-Mo Yang ◽  
Dong-A Kwon ◽  
Jung-Won Suh ◽  
Kyung-Woo Park ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Target Lesion ◽  
Controlled Study ◽  
Control Group ◽  
Cardiac Events ◽  
Open Label ◽  
Adverse Cardiac Events ◽  
Fatal Myocardial Infarction

Background: The effect of celecoxib on restenosis after angioplasty with a Taxus stent (COREA-TAXUS) trial is an open-label randomized controlled study, where we reported celecoxib was effective in reducing 6months late loss of Taxus stent. With this cohort, we analyzed long-term clinical outcomes. Method: Two hundred sixty seven patients underwent successful paclitaxel-eluting stents implantation for native coronary lesions. Patients were randomized to receive celecoxib (400 mg before the intervention, and 200 mg twice daily for 6 months after the procedure) or not. Clinical endpoints were cardiac death, non-fatal myocardial infarction, and revascularization of the target lesion. Results: At 6 months, frequency of adverse cardiac events was significantly lower in the celecoxib group (5.3% versus 16.2%, P=0.005), mainly because of reduced need for revascularization of the target lesion (5.3% versus 15.4%, P=0.009). Between 6 and 24 months, frequency of adverse cardiac events was not different between the celecoxib group and the control group (1.6% versus 4.4%, P=NS: 0% versus 0% for cardiac death; 0.8% versus 0.9% for non-fatal myocardial infarction; 0.8% versus 3.5% for revascularization of target lesion, P=all NS). At 2 years, frequency of adverse cardiac events was still significantly lower in the celecoxib group (6.9% versus 19.9%, P=0.002) Conclusion: In the COREA-TAXUS trial, the adjunctive use of celecoxib for 6 months after Taxus stent implantation was safe and clinically effective for 2 years.

scholarly journals Combination Preemptive Peripheral Nerve Block in Limb Surgery. A Prospective Study

Medicina ◽  
2020 ◽  
Vol 56 (8) ◽  
pp. 388
Author(s):  
I-Cheng Lu ◽  
Shu-Hung Huang ◽  
David Vi Lu ◽  
Chun Dan Hsu ◽  
Sheng Hua Wu
Keyword(s):  
Pain Management ◽  
Peripheral Nerve ◽  
Nerve Block ◽  
Peripheral Nerve Block ◽  
Recovery Period ◽  
Controlled Study ◽  
Control Group ◽  
Single Shot ◽  
Early Recovery ◽  
The Impact

Background and objectives: Patients often suffer from moderate to severe pain during the early recovery period in orthopedic surgery. We investigated the impact of a single-shot preoperative peripheral nerve block (PNB) on post-anesthesia recovery parameters and interleukin (IL)-6 level during limb surgery. Materials and Methods: A prospective randomized controlled study was conducted, and patients scheduled for limb surgery were recruited. Sixty patients were randomly assigned to either the PNB group or control group, who received morphine as a primary analgesic. The peak verbal numeric rating scale (NRS) score in the post-anesthesia care unit (PACU) was evaluated as a primary outcome. We also recorded rescue analgesics requirement and wake-up time from anesthesia in the PACU. In addition, the change of plasma IL-6 level after incision was measured. Results: Fifty-two patients completed the study, 27 and 25 cases in the PNB and control group, respectively. Preemptive PNB significantly reduced peak NRS score in the PACU compared to control group. Lower rescue analgesics requirement and rapid wake-up from anesthesia were also noted in PNB group. The IL-6 concentration increased less in the PNB group at 2 h after incision. Conclusions: Preemptive PNB attenuates IL-6 expression 2 h after incision and improves pain management in the PACU. PNB was considered as an essential part of pain management in limb surgery.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

Breaking immune tolerance for the treatment of glioblastoma: Phase IIb clinical trial experience.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 71-71
Author(s):  
Larn Hwang ◽  
David Nam ◽  
Vuong N. Trieu
Keyword(s):  
Immune Tolerance ◽  
Tumor Vaccine ◽  
Immune Surveillance ◽  
Tumor Development ◽  
Test Group ◽  
High Grade Glioma ◽  
Dose Finding ◽  
Control Group ◽  
Open Label ◽  
The Individual

71 Background: Intratumoral heterogeneity (IH) resulting in the temporal and spatial diversification of tumor subclones. IH occurs progressively during tumor development inherent to the individual predilection to mutation and in the face of counterselections by exogenous therapies and/or endogenous immune surveillance. The xenogenization is countered by immunosuppression via overexpression of TGF-β. Here we compare the use of temozolomide (TMZ) and OT-101/TMZ to break immune tolerance to glioblastoma (GBM) for the cure. OT-101 is an antisense against TGF-β2. Methods: This is a phase IIb, multi-national, multi-center, open-label, active-controlled, randomized parallel group dose-finding study to evaluate the efficacy and safety of OT-101 in adult patients with recurrent high-grade glioma, administered intratumorally as continuous high-flow microperfusion over a 7-day period every other week. A total of 134 patients, 89 patients in the OT-101 test group and 45 patients in the standard chemotherapy (TMZ) control group were assessed. Results: Multiple rounds of TMZ broke the immune tolerance as shown by increase in overall survival (OS). mOS increased from 5.6 mos, 7.9 mos, to 36.6 mos with 1 round, 2 rounds, and 3 rounds of TMZ, respectively (p<0.0001). For OT-101, mOS increased from 4.6 mos to 21.6 mos with just one round of TMZ (p<0.0001) reducing the negative side effects of TMZ. Treatment sequencing was important as lead-in OT101 followed with subsequent TMZ was more effective than TMZ prior to OT-101 (26.2 mos vs. 4.8 mos, p<0.0001). Conclusions: The MOA for OT-101/TMZ is consistent with the reactivation of immunity during TGF-β suppression and subsequent boosting/expansion of immunity during TMZ. Contrary to traditional tumor vaccine- this is universally applicable to all patients.

Preliminary safety and pharmacodynamic (PD) activity of XmAb20717, a PD-1 x CTLA-4 bispecific antibody, in a phase I dose escalation study of patients with selected advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15001-e15001
Author(s):  
Barbara Hickingbottom ◽  
Raphael Clynes ◽  
John Desjarlais ◽  
Caiyan Li ◽  
Ying Ding
Keyword(s):  
Solid Tumors ◽  
Dose Escalation ◽  
Clinical Symptoms ◽  
Standard Of Care ◽  
Advanced Solid Tumors ◽  
Open Label ◽  
Dose Escalation Study ◽  
Heavily Pretreated ◽  
Label Dose ◽  
Pretreated Patients

e15001 Background: Interim safety and PD data from an ongoing first-in-human, multi-center, open-label dose escalation study of XmAb20717 (XmAb20717-01; NCT03517488) are reported here. The primary objectives were to determine safety, tolerability, and the MTD and/or recommended doses (RDs). Secondary objectives included preliminary anti-tumor activity and PK/PD. Methods: A 3+3 dose escalation design was used to establish an MTD/RD(s) for infusions on Days 1 and 15 of each 28-day cycle. DLT evaluation was based on Cycle 1 through Day 28. Patients with selected solid tumors (in indications both with and without approved checkpoint therapy) who have exhausted standard of care are eligible. Results: As of 05FEB 2020, 34 patients were treated in cohorts 1-6 at fixed doses of 0.15 to 10 mg/kg. Patients had a median age of 57 years (range 32-81), a median time since initial diagnosis of 42 months (range 3 -313), and a median of 4 prior systemic therapies (range 0-9). 68% of patients had a TNM stage of III/IV, and 68% had been exposed to checkpoint therapy. XmAb20717 treatment was generally well tolerated through the highest dose cohort tested. Overall rates of Gr3/4 immune-related AEs occurred in 8 (24%) patients including elevations of transaminases 3 (9%), rash 2 (6%), lipase and amylase 1 (3%, without clinical symptoms or radiographic evidence of pancreatitis), lipase (alone) 1 (3%), pruritus 1 (3%), hyperglycaemia 1 (3%), arthritis 1 (3%) and colitis 1 (3%), all reversible. Responses were evaluated based on RECIST 1.1 criteria, and there was 1 CR reported (melanoma, progressed on prior pembrolizumab) at 10 mg/kg (highest dose level). Dose-dependent pharmacodynamic activity consistent with dual PD-1/CTLA-4 blockade was noted, namely a proliferative burst of both CD8 and CD4 T cells and induction of IFN-inducible chemokines (Table). Conclusions: XmAb20717 is generally safe and has demonstrated PD activity in heavily pretreated patients with selected advanced solid tumors. Dose escalation continues. Clinical trial information: NCT03517488 . [Table: see text]

Sorafenib as an adjuvant therapy for hepatocellular carcinoma with microvascular invasion after radical resection: A prospective multicenter nonrandomized controlled study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16685-e16685
Author(s):  
Li Xu ◽  
Yuhao Tang ◽  
Hua Li ◽  
Jie Zhou ◽  
Zhongguo Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Survival Data ◽  
Radical Resection ◽  
Microvascular Invasion ◽  
Controlled Study ◽  
Cancer Center ◽  
Control Group ◽  
Open Label ◽  
Recurrence Rates ◽  
Sorafenib Treatment

e16685 Background: Hepatocellular carcinoma (HCC) with microvascular invasion (MVI) is established with poorer outcome and more frequent postoperative recurrence. Sorafenib is the first target drug that successfully prolongs the survival of advanced HCC, but it failed to prolong the survival of HCC after radical resection or ablation in the STORM study. After that, series studies revealed that sorafenib could improve the survival of HCC with MVI after surgery, while most studies with positive results were retrospective ones. Methods: A multicenter, prospective non-randomized, open-label study was performed in pts undergoing radical resection, postoperative pathology confirming HCC with MVI (BCLC A or B stage; T2 or part T3aN0M0). Pts in the treatment group (S group) started sorafenib within 4-6 postoperative weeks at the dose of 400mg per day at most 2 years, and the control group (C group) never received sorafenib. The primary endpoint is recurrence-free survival (RFS) rate at the 2nd postoperative year, and the secondary endpoints include postoperative median time to recurrence (TTR), 1-year postoperative RFS, pts’ overall survival (OS), and safety. This study was approved by Ethical Committee of Sun Yat-sen University Cancer Center, and registered at ClinicalTrials.gov with number NCT02867280. Results: Between 1 June 2015 and 31 August 2019, 154 eligible pts from 3 academic hospitals in China were enrolled (83 in C group and 53 in S group). Baseline demographics were balanced between the two groups. The 2-yr RFS rate was 56.1% in the S group vs. 55.7% in the C group, respectively ( P = 0.955), and the median RFS was 15.5 vs. 16.0 months ( P = 0.827).The recurrence rates at the 1st postoperative year were 38.6% vs. 34.0% ( P = 0.568), and the median TTR was the same as the RFS. There were 31 pts (54.4%) of the S group experienced treatment-related adverse events (AEs). The most common AE was hand-foot syndrome (HFS, 19/57, 10 pts ≥ grade-2). Other AEs included diarrhoea (15/57, 26.4%), alopecia (11/57, 19.3%), hypertension (5/57, 8.8%) and decreased platelet (3/57, 5.3%), and gastric ulcer with bleeding (1/57, 1.8%). Sorafenib was interrupted or discontinued in 7 pts due to AEs. Recruiting of this study was closed according to the results of the planned mid-term analysis, and all pts were followed on schedule to observe the other survival data. Conclusions: Postoperative sorafenib treatment with dose of 400mg once daily was well tolerated, but did not improve the RFS and TTR of Chinese HCC pts with MVI. Clinical trial information: NCT02867280 .

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