Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma

Sponsor
Fudan University
Study ID
NCT04299581
Phase
PHASE2
Status
Recruiting
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Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    a PD-1 immune check inhibitor
  • US/CT-guided Percutaneous Cryoablation — COMBINATION_PRODUCT
    Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone

Study Details

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.

Key Dates

Start date
Jul 7, 2020
Status verified
Feb 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cryoablation in combination with Camrelizumab
    Cryoablation treatment starts at day 1. Camrelizumab will be initiated on day 14 after Cryoablation. Camrelizumab will be administered every three weeks (3mg/Kg, IV) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Primary Outcome Measure

Objective Response Rate [ Time Frame: max 24 months ]

Central Contacts

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