RecruitingPhase 2NCT06492408

Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.

Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma (HCC) Amenable for Surgical Resection

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

90 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Hepatic Cancer

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an approach where two immunotherapy drugs are injected directly into liver tumors (intra-tumor injection) before surgery in people with hepatocellular carcinoma (HCC, a type of liver cancer). Researchers want to see if this pre-surgical immune boost improves outcomes. **You may be eligible if...** - You have confirmed liver cancer (HCC) that has not been previously treated - You are a surgical candidate in your doctor's opinion - You have adequate overall health and organ function - You agree to a tissue biopsy for the study **You may NOT be eligible if...** - You have previously received treatment for HCC - Your cancer has spread outside the liver in a way that makes surgery impossible - You have active autoimmune disease requiring treatment - 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, 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, total 3-4 times. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks, total 3-4 times. 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, total 3-4 times.