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Lenvatinib Plus Tislelizumab With or Without Gefitinib for Advanced Liver Cancer

ConditionHepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lenvatinib

    Drug

    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.

  • Tislelizumab

    Drug

    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.

  • Gefitinib

    Drug

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Control group：Lenvatinib + TislelizumabActive comparator 2 interventions
Group B: Experimental group：Lenvatinib+Tislelizumab+GefitinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Treatment-Emergent Adverse Events

Treatment-emergent adverse events are defined as adverse events that occur or worsen after the start of study treatment. Adverse events will be coded and graded according to NCI CTCAE version 5.0. This outcome measure will report the number of participants who experience at least one treatment-emergent adverse event during the study.

Time frame
From the first dose of study treatment through 90 days after the last dose of study treatment
2

Progression-Free Survival

Progression-free survival is defined as the time from randomization to the first documented radiographic disease progression or death from any cause, whichever occurs first. Disease progression will be assessed by a blinded independent imaging review committee according to RECIST version 1.1.

Time frame
From randomization until disease progression or death from any cause, assessed up to 36 months

Secondary outcomes

1

Overall Survival

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From randomization until death from any cause, assessed up to 36 months
2

Objective Response Rate

Objective response rate is defined as the proportion of participants with a best overall response of complete response or partial response, as assessed according to RECIST version 1.1.

Time frame
From randomization until disease progression, start of new anticancer therapy, or study completion, assessed up to 24 months
3

Disease Control Rate

Disease control rate is defined as the proportion of participants with a best overall response of complete response, partial response, or stable disease, as assessed according to RECIST version 1.1.

Time frame
From randomization until disease progression, start of new anticancer therapy, or study completion, assessed up to 24 months
4

Duration of Response

Duration of response is defined for participants who achieve complete response or partial response as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.

Time frame
From first documented objective response until disease progression or death from any cause, assessed up to 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

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