Combining PD-L1 antibody and Bevacizumab with chemotherapy for advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of a combination treatment involving a PD-L1 antibody, Bevacizumab, and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) that has spread beyond the liver. The study is designed as a single-arm trial, meaning all participants will receive the same treatment regimen without a control group. Patients will receive the treatment every three weeks for up to 24 months or until disease progression. The primary goal is to assess the objective response rate, while secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety assessments, and quality of life measurements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Signed written informed consent Histologically/cytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed according to HCC diagnostic criteria Radiologically confirmed extrahepatic metastases with unresectable disease as evaluated by investigators No prior treatment with PD-L1 antibody and/or bevacizumab Age ≥18 and ≤75 years ECOG Performance Status 0-1 Child-Pugh Class A or B7 Able to comply with study protocol requirements At least one measurable or evaluable lesion according to RECIST v1.1

Adequate organ and bone marrow function:

Absolute neutrophil count ≥1.5×10\^9/L Platelet count ≥75×10\^9/L Hemoglobin ≥9.0 g/dL Total bilirubin ≤2×ULN ALT and AST ≤5×ULN Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min Urine protein \<2+ by dipstick APTT and INR ≤1.5×ULN Normal cardiac enzymes Normal thyroid function or on stable replacement therapy Life expectancy ≥12 weeks Effective contraception for participants of childbearing potential during treatment and for 6 months after last dose

Exclusion Criteria:

Severe complications from liver disease (severe bleeding from portal hypertension, infection, hepatic encephalopathy) Prior systemic anti-tumor therapy for HCC Other malignancy within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ) Current participation in other interventional clinical trials Systemic treatment with Chinese herbal medicine or immunomodulators within 2 weeks before first dose Active autoimmune disease requiring systemic treatment within 2 years Systemic corticosteroid therapy within 7 days before first dose Prior allogeneic organ transplantation (except corneal) or stem cell transplantation Known allergy to monoclonal antibodies or HAIC components Inadequate recovery from prior treatment toxicities Known HIV infection Untreated active HBV infection (HBsAg positive with HBV-DNA above upper limit of normal) Active HCV infection Live vaccine administration within 30 days before first dose Pregnancy or breastfeeding

Serious or uncontrolled systemic diseases including:

Significant cardiac arrhythmias or conduction abnormalities Unstable angina or NYHA class ≥2 heart failure Arterial thrombotic events within 6 months Uncontrolled hypertension Active interstitial lung disease Active tuberculosis Active systemic infections Active diverticulitis or GI obstruction Uncontrolled diabetes Significant proteinuria Psychiatric disorders affecting compliance Any condition that could interfere with study participation or interpretation of results

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yiwen Qiu, M.D.
• Email: qyw@wchscu.edu.cn
• Phone: +8613281003787

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.