Adjuvant Tislelizumab Plus Lenvatinib for Patients at High-risk of HCC Recurrence After Curative Resection or Ablation

NCT05910970 | Unknown Phase 3 DMC

• 1 other identifier: PREVENT-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy is reported.

Conditions

Hepatocellular Carcinoma; Recurrence; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

• Recurrene-free survival

  Recurrene-free survival will be calculated using the Kaplan-Meier method, and differences between groups are assessed for significance using the log-rank test.

  3 years

Secondary Outcomes (2)

• Overall survival

  3 years

• Adverse events

  1 years

Study Arms (2)

Adjuvant tislelizumab plus lenvatinib

EXPERIMENTAL

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC recurrence, or unacceptable adverse events.

Drug: Adjuvant tislelizumab plus lenvatinib

Adjuvant tislelizumab

ACTIVE COMPARATOR

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or unacceptable adverse events.

Drug: Adjuvant tislelizumab

Interventions

Adjuvant tislelizumab plus lenvatinib DRUG

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab plus lenvatinib treatment for six months, HCC recurrence, or unacceptable adverse events.

Adjuvant tislelizumab plus lenvatinib

Adjuvant tislelizumab DRUG

Patients at high-risk of hepatocellular carcinoma recurrence after curative resection or ablation will receive adjuvant tislelizumab treatment for six months, HCC recurrence, or unacceptable adverse events.

Adjuvant tislelizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years (inclusive);
• Diagnosis of HCC confirmed by postoperative histopathology;
• Underwent curative resection, as defined based on intra- and postoperative criteria;
• With high-risk factors of recurrence after curative treatment, based on preoperative radiological imaging or pathology reports indicating a tumor at least 5 cm in diameter, micro- or macrovascular invasion (Vp1/Vp2), satellite or multinodular tumors, and/or Grade 3/4 pathology;
• No residual cancer detected by radiological imaging in the liver within 8 weeks after curative resection;
• Child-Pugh 5-7 scores liver function;
• Eastern Cooperative Oncology Group performance status of 0 or 1.

You may not qualify if:

• Received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors before resection or ablation;
• A history of other malignancies;
• History of active autoimmune or immunodeficiency diseases;
• Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
• Loss to follow-up within six months.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Jian-Hong Zhong

Nanning, 530021, China

Location

Related Publications (5)

• Chen K, Wei W, Liu L, Deng ZJ, Li L, Liang XM, Guo PP, Qi LN, Zhang ZM, Gong WF, Huang S, Yuan WP, Ma L, Xiang BD, Li LQ, Zhong JH. Lenvatinib with or without immune checkpoint inhibitors for patients with unresectable hepatocellular carcinoma in real-world clinical practice. Cancer Immunol Immunother. 2022 May;71(5):1063-1074. doi: 10.1007/s00262-021-03060-w. Epub 2021 Sep 24.

  PMID: 34559308 BACKGROUND

• Zhong JH, Ma L, Li LQ. Postoperative therapy options for hepatocellular carcinoma. Scand J Gastroenterol. 2014 Jun;49(6):649-61. doi: 10.3109/00365521.2014.905626. Epub 2014 Apr 10.

  PMID: 24716523 BACKGROUND

• Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30.

  PMID: 32352320 BACKGROUND

• Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

  PMID: 26361969 BACKGROUND

• Li L, Wu PS, Liang XM, Chen K, Zhang GL, Su QB, Huo RR, Xie RW, Huang S, Ma L, Zhong JH. Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study. J Gastroenterol. 2023 Oct;58(10):1043-1054. doi: 10.1007/s00535-023-02018-2. Epub 2023 Jul 14.

  PMID: 37452107 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian-Hong Zhong, Ph.D

  Guangxi Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Hong Zhong, Ph.D

CONTACT

+86 771 5301253; zhongjianhong@gxmu.edu.cn

Liang Ma, MD

CONTACT

0771 5301253; malianggxyd@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 20, 2023
• Study Start: February 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the study is completed and publication in a journal.

Locations

CN (1)