NCT06742424

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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: * Confirmed extrahepatic metastases * No prior PD-L1 or bevacizumab therapy * Age 18-75 years * Child-Pugh A or B7 liver function * ECOG performance status 0-1 Treatment Regimen: * PD-L1 antibody: 1200mg every 3 weeks * Bevacizumab: 15mg/kg every 3 weeks * HAIC with FOLFOX regimen: Up to 6 cycles * Treatment continues until disease progression or up to 24 months Primary Endpoint: -Objective Response Rate (ORR) Secondary Endpoints: * Disease Control Rate (DCR) * Duration of Response (DOR) * Progression-free Survival (PFS) * Overall Survival (OS) * Safety assessments * Quality of life measurements Study Design Details: * Single-arm study using Simon's two-stage design * First stage: 27 patients * Second stage: 9 additional patients if first stage shows efficacy * Total planned enrollment: 36 patients * Study duration: October 2024 - July 2027 This study aims to evaluate whether adding HAIC to PD-L1 inhibitor plus bevacizumab immunotherapy can improve outcomes for advanced HCC patients with extrahepatic spread, who currently have limited treatment options. The trial will assess both efficacy and safety of this combination approach.

Conditions

• Hepato Cellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	PD-L1 antibody	1200mg intravenously every 3 weeks
DRUG	Bevacizumab	15mg/kg intravenously every 3 weeks
PROCEDURE	HAIC-FOLFOX	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

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-04-30
• Completion: 2027-07-30
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: China