MedTrace Logo

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

NCT06742424 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-12-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-04-30
Completion
2027-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06742424 on ClinicalTrials.gov