NCT07829926Not yet recruitingPhase 2
Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer
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)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2026
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07829926
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From Nov 2026 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anticancer therapy for hepatocellular carcinoma.
- Prior treatment with an epidermal growth factor receptor inhibitor.
- Major surgery, locoregional therapy, radiotherapy, or other anticancer therapy within the protocol-defined washout period before randomization.
Other illness
- 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.
- 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.
- 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.
Other
- Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-hepatocellular carcinoma histology.
- Clinically significant ascites, hepatic encephalopathy, or other evidence of hepatic decompensation.
- Untreated or symptomatic central nervous system metastases.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.