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New treatment option for Hepato Cellular Carcinoma (HCC)
Official title PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC
ClinicalTrials.gov ID: NCT06742424
What this study is testing
What is PD-L1 antibody?
PD-L1 antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepato cellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed written informed consent Histologically/cytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed according to HCC...
- 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...
You likely can't join if
- Severe complications from liver disease (severe bleeding from portal hypertension, infection, hepatic encephalopathy) Prior systemic anti-tumor...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.