RecruitingPhase 2NCT06482801

Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT

Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and/or Bevacizumab Therapy as First Line for Hepatocellular Carcinoma


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

90 participants

Start Date

Jun 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two checkpoint inhibitor immunotherapy drugs — given directly into liver tumors — can work as a first-line treatment for hepatocellular carcinoma (HCC), which is the most common form of liver cancer. Delivering the drugs directly into the tumor (called intratumoral injection) may boost the immune response with fewer side effects. **You may be eligible if...** - You are over 18 with liver cancer confirmed by biopsy or imaging - Your estimated survival is more than 3 months - Your liver function is adequate (Child-Pugh class A or B) - Your blood counts and organ function meet the required thresholds - You have at least one measurable tumor **You may NOT be eligible if...** - You have previously participated in another clinical trial for this condition - Your liver function is severely impaired (Child-Pugh class C) - You have active autoimmune disease or are on immunosuppressants - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab

This study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks.


Locations(1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

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NCT06482801


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