scholarly journals P01.01 Safety and Efficacy Study of Pembrolizumab in Combination With LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant as Neoadjuvant TherapY——PLENTY Randomized Clinical Trial

2021 ◽  
Vol 9 (Suppl 1) ◽  
pp. A3.1-A3
Author(s):  
H Feng ◽  
Q Xia ◽  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplant ◽  
Neoadjuvant Therapy ◽  
Objective Response ◽  
Neoadjuvant Treatment ◽  
Milan Criteria ◽  
Full Time ◽  
Safety And Efficacy ◽  
Neoadjuvant Immunotherapy ◽  
Block Randomization

BackgroundPatients with hepatocellular carcinoma (HCC) who exceed standard Milan criteria suffered from high post-transplant recurrence rate.This study will evaluate the safety and efficacy of pembrolizumab in combination with lenvatinib as neoadjuvant therapy in participants with HCC exceeding Milan criteria before liver transplant.Materials and MethodsParticipates would be randomly assigned (1:1) to experimental or Comparator/Control by computer-generated allocation based on the envelope method and the hierarchical block randomization method(hierarchy: BCLC stage and AFP level). The envelopes are sealed opaque, and sequentially numbered.Randomization is performed by the trial coordinator.The random number table and the block assignment number table will be kept confidential by the full-time secretary of this project.Center-stratified block-permuted randomization is used in this trial. Then permuted block randomization is used for each stratum with a block size of 4.ResultsThe initial first patient was recruited in August.2020, the primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) Objective Response Rate (ORR).The investigators design a clinical study to explore whether the combination above as a neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce postoperative recurrence and to analyze potential immune biomarker of therapeutic response.ConclusionsThe study is still ongoing and the preliminary short term outcome was positive. HCC patients who exceeded milan criteria may benefit from neoadjuvant immunotherapy combined with TKI before liver transplantation.Disclosure InformationH. Feng: None. Q. Xia: None.

Use of yttrium-90 (Y90) glass microspheres (TheraSphere) as neoadjuvant to transplantation/resection in hepatocellular carcinoma: Analyses from the LEGACY study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 300-300
Author(s):  
Robert Lewandowski ◽  
Guy E. Johnson ◽  
Edward Kim ◽  
Ahsun Riaz ◽  
Vivian Bishay ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Partial Response ◽  
Neoadjuvant Therapy ◽  
Objective Response ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
The United States ◽  
Glass Microspheres ◽  
Eligibility Criteria ◽  
Yttrium 90

300 Background: The objective of the LEGACY study was to assess the Objective Response Rate (ORR) and Duration of Response (DoR) following treatment with Yttrium-90 (Y90) glass microspheres in patients with unresectable solitary hepatocellular carcinoma (HCC). The objective of the analyses presented here are to evaluate ORR, DoR, and Overall Survival (OS) by transplant/resection status and to compare these outcomes with patients who did not go on to transplantation/resection after receiving treatment with Y90. Methods: LEGACY is a single-arm, multicenter, retrospective study of patients with unresectable HCC who received treatment with Y90 glass microspheres (TheraSphere) at one of three sites in the United States. LEGACY included all consecutive eligible patients who received treatment between January 2014 and December 2017 and met the eligibility criteria (Child-Pugh A; ECOG score of 0 or 1; BCLC A or C; and a solitary tumor > 2 and ≤8 cm). Primary efficacy endpoints included ORR and DoR. ORR included patients who achieved either a complete response or partial response based on localized mRECIST; response was assessed via blinded, independent, central review. Secondary endpoints include OS and number and type of subsequent treatments, including transplantation and resection. Results: Among all 162 patients enrolled in LEGACY, ORR was 72.2% (117/162; 95% CI = 64.9%, 78.5%); the majority of patients experienced DoR ≥ 6 months (89/117, 76.1%, 95% CI = 67.6%, 82.9%). Median follow-up time for all 162 patients enrolled in LEGACY was 29.9 months by reverse Kaplan-Meier analysis; 3-year OS was 86.6%. For 45/162 (27.8%) of patients, Y90 treatment served as neoadjuvant therapy; 34 went on to transplantation (21.0%) and 11 (6.8%) went on to resection. For neoadjuvant treatment, ORR was 80.0% (36/45, 95% CI = 66.2, 89.1), DoR ≥ 6 months was 30.6% (11/45, 95% CI = 18.0, 46.9), and 3-year OS was 92.8% (95% CI = 74.2, 98.2). Of these 45 patients, 35 patients achieved complete response (CR), 1 achieved partial response (PR), and 9/45 (20.0%) were deemed not evaluable as they underwent surgery prior to the 6-month mark and did not have imaging assessments post-Day 46. These nine patients were censored, lowering the DoR; however, histopathology revealed that 7/9 (77.8%) achieved complete pathologic necrosis, 1/9 (11.1%) had extensive pathologic necrosis, and 1 (11.1%) had partial pathologic necrosis. For the 117/162 (72.2%) patients who did not go on to surgical treatment, ORR was 91.5% (107/117, 95% CI = 85.0, 95.3), DoR ≥ 6 months was 72.9% (78/117, 95% CI = 63.8, 80.4), and 3-year OS was 83.5% (95% CI = 72.2, 90.5). Conclusions: Treatment of solitary unresectable HCC with Y90 glass microspheres provides strong ORR, DoR, and OS both as neoadjuvant therapy to transplantation/resection and as treatment in non-surgical candidates.

Adjuvant versus Neoadjuvant Immunotherapy for Hepatocellular Carcinoma: Clinical and Immunologic Perspectives

2021 ◽  
Author(s):  
Yung-Yeh Su ◽  
Chia-Chen Li ◽  
Yih-Jyh Lin ◽  
Chiun Hsu
Keyword(s):  
Hepatocellular Carcinoma ◽  
Neoadjuvant Therapy ◽  
Systemic Therapy ◽  
Therapeutic Benefit ◽  
Advanced Hepatocellular Carcinoma ◽  
Curative Therapy ◽  
Trial Conduct ◽  
Neoadjuvant Immunotherapy ◽  
Stage Disease ◽  
Result Analysis

AbstractAdvancement in systemic therapy, particularly immune checkpoint inhibitor (ICI)-based combination regimens, has transformed the treatment landscape for patients with advanced hepatocellular carcinoma (HCC). The advancement in systemic therapy also provides new opportunities of reducing recurrence after curative therapy through adjuvant therapy or improving resectability through neoadjuvant therapy. Improved recurrence-free survival by adjuvant or neoadjuvant ICI-based therapy has been reported in other cancer types. In this article, developments of systemic therapy in adjuvant and neoadjuvant settings for HCC were reviewed. The design of adjuvant and neoadjuvant therapy using ICI-based regimens and potential challenges of trial conduct and result analysis was discussed. Results from these trials may extend the therapeutic benefit of ICI-based systemic therapy beyond the advanced-stage disease and lead to a new era of multidisciplinary management for HCC.

Camrelizumab combined with paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma (ESPRIT): A phase Ⅱ, single-arm, exploratory research.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16033-e16033
Author(s):  
Jianqun Ma ◽  
Jinfeng Zhang ◽  
Yingnan Yang ◽  
Dayong Zheng ◽  
Xiaoyuan Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Neoadjuvant Therapy ◽  
Squamous Cell ◽  
Radical Surgery ◽  
Objective Response ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Therapeutic Effects

e16033 Background: Camrelizumab has been approved as a standard therapy in the second-line treatment of esophageal squamous cell carcinoma (ESCC). This study aimed to explore the efficacy and safety of camrelizumab combined with commonly used neoadjuvant chemotherapy (paclitaxel and platinum) in neoadjuvant treatment of ESCC. Methods: In this single-arm, phase Ⅱ study, patients with advanced ESCC who were expected to receive neoadjuvant therapy followed by radical surgery were recruited. The patients received 2-4 cycles of camrelizumab (200mg, iv, q3w) in combination with paclitaxel (155mg/m2, iv, q3w) and nedaplatin (80mg/m2, iv, q3w) as neoadjuvant therapy, and the therapeutic effects were determined every 2 cycles. The radical surgery was performed on patients whose tumors were evaluated as resectable. The primary endpoint was pCR, and the secondary endpoints were objective response rate (ORR) and disease control rate (DCR). Results: From May 2020 to January 2021, 24 patients with a median age of 60.5 years (50-73) were enrolled. Among them, 21 patients were available for efficacy analysis, of which 1 achieved complete response (CR), 7 achieved partial response (PR), and 13 had stable disease (SD). The ORR was 38.1% and DCR was 100%. The tumor in 10 patients shrank significantly after neoadjuvant therapy and these patients preferred radiotherapy instead of surgery as the radical therapeutic method. 2 patients abandoned surgery because of personal reasons. 2 patients were in the process of neoadjuvant therapy and had not undergone surgery yet. The remaining 7 patients underwent radical surgery and 4 patients (57.14%) achieved pCR (pT0N0M0). The main treatment-related grade 3/4 adverse event (AE) was neutropenia (1/21). All the AEs were manageable. The average intraoperative blood loss was 221mL and the average hospitalization time after operation was 12.7 days (range 8-19 days). No anastomotic leakage and treatment-related death occurred. Conclusions: Camrelizumab in combination with paclitaxel and platinum as a neoadjuvant therapy was well tolerated. The pCR rate of 57.14% was higher than the expected 40%. This encouraging result promoted us to continue this phase Ⅱ study. Clinical trial information: ChiCTR2000033761.

Hepatocellular Carcinoma Recurrence Among Liver Transplant Recipients Within the Milan Criteria

2012 ◽  
Vol 44 (8) ◽  
pp. 2459-2461 ◽  
Author(s):  
G. Felga ◽  
A.S. Evangelista ◽  
P.R. Salvalaggio ◽  
L.A. Curvelo ◽  
B. Della Guardia ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplant ◽  
Milan Criteria ◽  
Transplant Recipients ◽  
Hepatocellular Carcinoma Recurrence ◽  
Liver Transplant Recipients

Liver Transplantation for Locally Advanced Hepatocellular Carcinoma

2020 ◽  
Vol 04 (01) ◽  
pp. 003-012
Author(s):  
Norio Kawamura ◽  
Akinobu Taketomi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Transplantation ◽  
Liver Transplant ◽  
Early Stage ◽  
Locally Advanced ◽  
Tumor Biology ◽  
Locoregional Therapy ◽  
Milan Criteria ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc

AbstractSince the Milan criteria were accepted as the gold standard, liver transplantation has been widely performed as a curative treatment for early-stage hepatocellular carcinoma (HCC). The outcome of liver transplantation in early-stage HCC is excellent; however, the Milan criteria are strict, and therefore, only limited numbers of patients can benefit from liver transplantation. Many HCC patients are diagnosed at an advanced stage, which falls outside the Milan criteria, so it has been proposed over the last two decades that liver transplant surgeons should perform liver transplantation in locally advanced HCC, when presenting without recurrence. Several trials exploring the upper limits of liver transplantation have been performed, and extensive research on tumor biology has enabled the expansion of liver transplant indication for HCC. Simultaneously, locoregional therapy for advanced HCC was found to be an effective procedure when used to distinguish potentially transplantable patients. This treatment approach, known as a downstaging strategy, has been developed over the last two decades and became an essential treatment option for locally advanced HCC. In this article, the current strategies of liver transplantation for the treatment of locally advanced HCC are reviewed.

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