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NCT06742424

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

Recruiting now Phase 2 Last updated 19 December 2024
What this trial tests

Phase 2 trial testing PD-L1 antibody in Hepato Cellular Carcinoma (HCC) in 36 participants. Currently enrolling.

Timeline
1 October 2024
Primary endpoint
30 April 2027
30 July 2027

Quick facts

Lead sponsorWest China Hospital
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date1 October 2024
Primary completion30 April 2027
Estimated completion30 July 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

West China Hospital

Who can join

Adults 18 to 75, any sex, with Hepato Cellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of PD-L1 antibody

Trials testing the same drug.

Other recruiting trials for Hepato Cellular Carcinoma (HCC)

Currently open trials in the same condition.

Other West China Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06742424.

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