A randomized phase II study of gemcitabine (G) plus the cardiac glycoside huachansu (H) in the treatment of patients with locally advanced (LAPC) or metastatic pancreatic cancer (MPC).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 284-284 ◽  
Author(s):  
Z. Meng ◽  
L. Liu ◽  
Y. Shen ◽  
P. Yang ◽  
L. Cohen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Phase Ii ◽  
Cardiac Glycoside ◽  
Demographic Data ◽  
Locally Advanced ◽  
Preliminary Evidence ◽  
Toad Skin ◽  
Significant Difference

284 Background: Wild toad venom has been used for over 1,000 years as a traditional Chinese medicine; H, the extract of dried toad skin glands, is a potent cardiac glycoside without significant toxicity. H has demonstrated preliminary evidence of antitumor activity in phase I clinical trial evaluation (Cancer 2009, 115:5309-18). Methods: We conducted a randomized, single-blind, phase II clinical trial of G + H versus G + placebo in patients with LAPC or MPC. Plasma bufalin levels were performed in H-treated subjects. 80 evaluable subjects accrued from October 2007 to May 2010 and were treated with G 1,000mg/m2 (iv on days 1, 8, 15, q 28d) plus either H (20 mL/m2 iv daily for 21 days followed by 7 days off, q 28d) or placebo. Demographic data is demonstrated in the table below. Results: Grade 3/4 adverse events, objective radiographic response rates (ORR), time to progression (TTP), quality of life (QOL), and overall survival (OS) were similar in the two groups (Table). There was not a statistically significant difference in the average plasma bufalin levels in patients with a radiographic partial response (PR) or stable disease versus those with progressive disease (PD) (0.098 ± 0.093 ng/mL vs. 0.071 ± 0.048 ng/mL, p=0.679). Conclusions: H when added to G was well tolerated but did not improve OS, TTP, QOL, or ORR. Further investigation of a more potent oral formulation of H is planned. H provided by Shenzhen 999 Traditional Chinese Medicine & Development Co., Ltd. Supported by NIH U19CA121503-01. [Table: see text] No significant financial relationships to disclose.

Phase II study of preoperative chemotherapy plus bevacizumab with early salvage therapy based on FDG-PET response in patients with locally advanced gastric and GEJ adenocarcinoma.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 94-94
Author(s):  
Elizabeth Won ◽  
David Ilson ◽  
David Paul Kelsen ◽  
Vivian E. Strong ◽  
Heiko Schöder ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Salvage Therapy ◽  
Fdg Pet ◽  
Locally Advanced ◽  
Salvage Chemotherapy ◽  
Pet Scan ◽  
R0 Resection ◽  
Significant Difference

94 Background: Response on FDG-PET scan during preoperative chemotherapy has prognostic significance. PET non-responders do poorly whether they continue the same chemotherapy or proceed directly to surgery [JCO 24: 4692; 2006, Lancet Onc 8:797;2007) Early identification of treatment failure using PET scan may spare patients (pts) from inactive therapy and allow for cross-over to alternative therapies. We performed a phase II trial to examine the effectiveness of FDG-PET directed early switching to salvage chemotherapy measured by 2 year disease free survival (DFS) in the PET non-responding group. Methods: Pts with PET avid, EUS and laparoscopically staged T3 or Node positive resectable gastric or GEJ adenocarcinoma received induction with epirubicin 50mg/m2, cisplatin 60mg/m2, capecitabine 625mg/m2 bid days 2-21(ECX) and bevacizumab 15mg/kg day 1. PET scan was repeated at week 3. PET responders (≥35% decline in SUV) continued ECX for 2 more cycles. PET non-responders switched to 2 cycles of salvage therapy: docetaxel 30mg/m2 d1, d8 q21 days, irinotecan 50mg/m2 d1, d8 q21 days and bevacizumab 15mg/kg day 1. Pts had surgery 4 weeks after cycle 3. Results: 20 of planned 60 pts were enrolled before the study closed for poor accrual. 14 male (64%), 8 female (39%), median age 62, median KPS 90. 11(55%) had a PET response after the first cycle. 10/11 (91%) underwent R0 resection: 1/10 pathologic CR, 3/10 pathologic PR. 9/20 PET non-responders switched to the salvage regimen. 7/9 Non-responders had R0 resection, none achieved a pathological response. The DFS for PET responders was 27.8mos (95% CI 10.3-27.8) and DFS in salvage group has not been reached. There was no significant difference in DFS between the two groups (p= 0.4). Follow up for overall survival is ongoing. Biologic correlative studies are pending. Conclusions: Response on PET scan during induction chemotherapy can identify early treatment failures. The results for therapy cross-over indicate a potentially improved DFS with salvage chemotherapy. Results from this trial are hypothesis generating and merit evaluation in a larger clinical trial. Supported by a grant from Genentech. Clinical trial information: NCT00737438.

Evolutionary action score of TP53 analysis in pathologically high-risk HPV-negative head and neck cancer from a phase II clinical trial: NRG Oncology RTOG 0234.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6010-6010
Author(s):  
Chieko Michikawa ◽  
Pedro A. Torres-Saavedra ◽  
Natalie L. Silver ◽  
Paul M. Harari ◽  
Merrill S. Kies ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Head And Neck ◽  
Prognostic Marker ◽  
Phase Ii ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Missense Mutations ◽  
Pathologic Features ◽  
Significant Difference

6010 Background: An evolutionary action scoring algorithm (EAp53) based on phylogenetic sequence variations and speciation stratifies head and neck squamous cell carcinoma (HNSCC) patients bearing TP53 missense mutations as high-risk (high, EAp53≥75), associated with poor outcomes, or low-risk (low), with similar outcomes as TP53 wild-type (wt), and has been validated as a reliable prognostic marker. This study is designed to further validate prior findings that EAp53 is a prognostic marker for locally advanced HNSCC patients, and assess its predictive value for treatment outcomes to adjuvant bio-chemoradiotherapy. Methods: Eighty one resection specimens from patients treated surgically for stage III or IV human papillomavirus-negative (HPV(-)) HNSCC with high-risk pathologic features, who received either Arm 1) radiotherapy(RT)+cetuximab(CTX)+cisplatin or Arm 2) RT+CTX+docetaxel, as adjuvant treatment in a phase II randomized clinical trial (RTOG 0234) underwent TP53 targeted sequencing, and EAp53 scoring. The EAp53 scores were correlated with clinical outcomes. Due to limited sample sizes, patients were combined into 2 EAp53 groups: wt/low and high/other. Results: At median follow-up of 10 years, there was a significant interaction between treatment and EAp53 group for overall survival (OS) (p = 0.008), disease-free survival (DFS) (p = 0.05) and distant metastasis (DM) (p = 0.004). Within arm 2, high/other showed worse OS [HR 4.69 (1.52-14.50)], DFS [HR 2.69 (1.16-6.21)], and had higher DM [HR 11.71 (1.50-91.68)] than wt/low. Within arm 1, there was no significant difference by EAp53 in OS, DFS and DM. Within the wt/low group, arm 2 had better OS [HR 0.11 (0.03-0.36)], DFS [HR 0.24 (0.09-0.61)], and DM [HR 0.04 (0.01-0.31)] than arm 1 but this was not found in high/other. Conclusions: High/other EAp53 scores were associated with worse survival for patients in arm 2. Arm 2 is associated with better survival than arm 1 for patients with wt/low EAp53. This benefit appears to be largely driven by a reduction in DM. Further validation is required to determine whether EAp53 can be used for personalized post-operative treatment decisions in HPV(-) HNSCC.

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals The Changes in The Utilization Rate of Traditional Chinese Medicine During the 2019 Coronavirus Pandemic

2020 ◽  
Author(s):  
Shun-Ku Lin ◽  
Chien-Tung Wu ◽  
Chia-Jen Liu ◽  
Hui-Jer Chou ◽  
Fu-Yang Ko ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Rural Areas ◽  
Utilization Rate ◽  
City Hospital ◽  
Medical Needs ◽  
Mobile Medicine ◽  
Number Of Patients ◽  
Significant Difference ◽  
The Impact

Abstract Background: Large-scale epidemics have changed people’s medical behavior, and patients tend to delay non-urgent medical needs. However, the impact of the pandemic on the use of complementary and alternative medicine remains unknown. Methods: This retrospective study aimed to analyze the changes in the number of traditional Chinese medicine (TCM) patients and examine the epidemic prevention policy during the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the number of TCM patients in Taipei City Hospital from January 2017 to May 2020. We tallied the numbers of patients in each month and compared them with those in the same months last year. We calculated the percentage difference in the number of patients to reveal the impact of the COVID-19 pandemic on TCM utilization. We used the Mann­–Whitney U test to examine whether there was a significant difference in the number of patients during the COVID-19 pandemic. Results: We included a total of 41 months and 1,935,827 patients in this study. During the COVID-19 pandemic, the number of patients decreased significantly, except in February 2020. The numbers of patients during the COVID-19 pandemic had fallen by more than 15% compared with those in the same months last year. March and April had the greatest number of patient losses, with falls of 32.8% and 40%, respectively. TCM patients declined significantly during the COVID-19 pandemic, and mobile medicine provided to rural areas fell considerably. Among all the TCM specialties, pediatrics and traumatology, as well as infertility treatment, witnessed the most significant decline in the number of patients. However, the number of cancer patients has reportedly increased. Conclusions: The COVID-19 pandemic decreased the utilization rate of TCM, especially for mobile healthcare in rural areas. We suggest that the government pay attention to the medical disparity between urban and rural areas, which are affected by the pandemic, as well as allocate adequate resources in areas deprived of medical care.

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