PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC

Phase 2

Recruiting

• Conditions: Hepato Cellular Carcinoma (HCC)
• Interventions: Drug: PD-L1 antibody; Drug: Bevacizumab; Procedure: HAIC-FOLFOX

• Registration Number: NCT06742424
• Lead Sponsor: West China Hospital

Brief Summary

This is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases.

Study Population: Patients with advanced HCC who have:
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-04-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX	PD-L1 antibody	Participants will receive: * PD-L1 antibody 1200mg intravenously every 3 weeks * Bevacizumab 15mg/kg intravenously every 3 weeks * HAIC-FOLFOX regimen (up to 6 cycles) consisting of: * Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours * Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours * Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours * HAIC treatment repeats every 3 weeks for up to 6 cycles After completion of HAIC, participants will continue to receive PD-L1 antibody and bevacizumab until disease progression, unacceptable toxicity, or up to 24 months of treatment. Tumor assessments will be performed every 9 weeks for the first 48 weeks, then every 12 weeks thereafter.
PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX	Bevacizumab	Participants will receive: * PD-L1 antibody 1200mg intravenously every 3 weeks * Bevacizumab 15mg/kg intravenously every 3 weeks * HAIC-FOLFOX regimen (up to 6 cycles) consisting of: * Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours * Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours * Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours * HAIC treatment repeats every 3 weeks for up to 6 cycles After completion of HAIC, participants will continue to receive PD-L1 antibody and bevacizumab until disease progression, unacceptable toxicity, or up to 24 months of treatment. Tumor assessments will be performed every 9 weeks for the first 48 weeks, then every 12 weeks thereafter.
PD-L1 Antibody + Bevacizumab + HAIC-FOLFOX	HAIC-FOLFOX	Participants will receive: * PD-L1 antibody 1200mg intravenously every 3 weeks * Bevacizumab 15mg/kg intravenously every 3 weeks * HAIC-FOLFOX regimen (up to 6 cycles) consisting of: * Oxaliplatin 130 mg/m² via hepatic arterial infusion over 3 hours * Leucovorin 400 mg/m² via hepatic arterial infusion over 2 hours * Fluorouracil 400 mg/m² bolus via hepatic arterial infusion at hour 5, followed by 2400 mg/m² continuous hepatic arterial infusion over 46 hours * HAIC treatment repeats every 3 weeks for up to 6 cycles After completion of HAIC, participants will continue to receive PD-L1 antibody and bevacizumab until disease progression, unacceptable toxicity, or up to 24 months of treatment. Tumor assessments will be performed every 9 weeks for the first 48 weeks, then every 12 weeks thereafter.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) as Assessed by RECIST v1.1	From first dose until disease progression or up to 24 months of treatment, with tumor assessments performed every 9 weeks for the first 48 weeks and every 12 weeks thereafter.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China