Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT06492408
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hepatic Cancer
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2024
Primary completion
Dec 30, 2028
Completion
Dec 30, 2033

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: IT injection of double ICIs
    Neoadjuvant therapy: intra-tumor injection of double ICIs only.
  • Experimental: Group 2: IT injection of double ICIs and chemodrug
    Neoadjuvant therapy: intra-tumor injection of double ICIs and chemodrug.
  • Experimental: Group 3: IT injection of double ICIs and chemodrug plus bevacizumab
    Neoadjuvant therapy: intra-tumor injection of double ICIs and chemodrug plus bevacizumab.

Primary Outcome Measure

pCR rate for the study groups [ Time Frame: Six months ]

Central Contacts

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