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NCT07829926

PHASE2

Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

Summary

This study is for people with unresectable or advanced hepatocellular carcinoma who have not received previous systemic treatment for liver cancer. The study will compare lenvatinib plus tislelizumab with or without gefitinib. Participants will be randomly assigned to receive either lenvatinib, tislelizumab, and gefitinib, or lenvatinib and tislelizumab. The study is open-label, so participants and study doctors will know the treatment group. The main outcomes are progression-free survival and the number of participants with adverse events of special interest. Progression-free survival is the time from randomization until the cancer gets worse or the participant dies. Adverse events of special interest are predefined side effects that require close monitoring. The study will also evaluate tumor response, overall survival, other side effects, and exploratory biomarkers.

Official title: A Randomized, Open-Label Phase II Trial of Lenvatinib Plus Tislelizumab With or Without Gefitinib as First-Line Treatment for Unresectable or Advanced Hepatocellular Carcinoma (LENTIG-HCC Study)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11

Completion Date

2028-11

Last Updated

2026-09-21

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Lenvatinib

Lenvatinib will be administered orally once daily. The dose will be based on baseline body weight: 8 mg once daily for participants weighing less than 60 kg and 12 mg once daily for participants weighing 60 kg or more. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of new anticancer therapy, death, or other protocol-defined discontinuation criteria.

DRUG

Tislelizumab

Tislelizumab will be administered by intravenous infusion at a dose of 200 mg on Day 1 of each 21-day cycle. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of new anticancer therapy, death, or other protocol-defined discontinuation criteria.

DRUG

Gefitinib

Gefitinib will be administered orally at a dose of 250 mg once daily in the experimental arm. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of new anticancer therapy, death, or other protocol-defined discontinuation criteria.

Inclusion Criteria： * Age 18 to 75 years, male or female. * Histologically or clinically/radiologically confirmed hepatocellular carcinoma. * Unresectable or advanced hepatocellular carcinoma requiring systemic therapy. * No prior systemic anticancer therapy for hepatocellular carcinoma. * At least one measurable lesion according to RECIST version 1.1. * Eastern Cooperative Oncology Group performance status of 0 to 1. * Child-Pugh class A liver function. * Life expectancy of at least 12 weeks. * Adequate hematologic, hepatic, renal, and coagulation function as defined in the protocol. * For participants with hepatitis B virus infection, antiviral therapy must be given according to local practice, and hepatitis B virus DNA must meet protocol-defined requirements. * Participants of childbearing potential must agree to use effective contraception during the study and for the protocol-defined period after the last dose of study treatment. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria： * Prior systemic anticancer therapy for hepatocellular carcinoma. * Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-hepatocellular carcinoma histology. * Prior treatment with an epidermal growth factor receptor inhibitor. * Uncontrolled hypertension, clinically significant cardiovascular disease, or serious bleeding or thrombotic events within the protocol-defined period. * Active or high-risk gastrointestinal bleeding, untreated or inadequately treated esophageal or gastric varices, or clinically significant coagulation disorder. * History of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or active pneumonitis. * Active autoimmune disease or history of autoimmune disease requiring systemic treatment, except as allowed by the protocol. * Active uncontrolled infection, including uncontrolled hepatitis B virus infection or hepatitis C virus infection requiring treatment but not adequately controlled. * Known human immunodeficiency virus infection with uncontrolled disease, if applicable according to local regulations. * Clinically significant ascites, hepatic encephalopathy, or other evidence of hepatic decompensation. * Untreated or symptomatic central nervous system metastases. * Major surgery, locoregional therapy, radiotherapy, or other anticancer therapy within the protocol-defined washout period before randomization. * Inability to swallow oral medication or any condition that may significantly affect absorption of oral study drugs. * Known allergy or hypersensitivity to lenvatinib, tislelizumab, gefitinib, or any of their excipients. * Pregnancy or breastfeeding. * Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study or interfere with study treatment, safety evaluation, or protocol compliance.

Clinical Research Directory

Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria