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

Conditions

• Hepato Cellular Carcinoma (HCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• PD-L1 antibody — DRUG
  1200mg intravenously every 3 weeks
• Bevacizumab — DRUG
  15mg/kg intravenously every 3 weeks
• HAIC-FOLFOX — PROCEDURE
  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

Study Details

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.

Key Dates

First listed

Dec 19, 2024

Start date

Oct 1, 2024

Status verified

Dec 2024

Primary completion

Apr 30, 2027

Completion

Jul 30, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: PD-L1 Antibody + Bevacizumab + 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 Measure

Objective Response Rate (ORR) as Assessed by RECIST v1.1 [ Time Frame: 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. ]

Central Contacts

• Yiwen Qiu, M.D.
  +8613281003787
  [email protected]