Combining PD-L1 antibody and Bevacizumab with chemotherapy for advanced liver cancer
Efficacy and Safety of PD-L1 Antibody Combined With Bevacizumab and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma With Extrahepatic Metastases: A Single-Arm, Prospective, Phase II Clinical Study
This study is testing a new combination of treatments for people with advanced liver cancer to see if it can help them live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06742424 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed advanced HCC and extrahepatic metastases who have not previously received PD-L1 or Bevacizumab therapy.
Not a fit: Patients with prior treatment involving PD-L1 antibodies or Bevacizumab, or those with Child-Pugh Class C liver function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with advanced liver cancer that has metastasized, potentially leading to better survival rates and quality of life.
How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy with chemotherapy for liver cancer have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Yiwen Qiu, M.D.
- Email: qyw@wchscu.edu.cn
- Phone: +8613281003787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.