RecruitingPhase 2NCT04299581

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

A Phase II Study of Cryoablation Combined with Anti-PD-1 Antibody (SHR-1210) in Patients with Advanced Intrahepatic Cholangiocarcinoma


Sponsor

Fudan University

Enrollment

25 participants

Start Date

Jul 7, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining cryoablation (using extreme cold to destroy tumors) with an immunotherapy drug (an anti-PD-1 antibody) can treat advanced bile duct cancer (intrahepatic cholangiocarcinoma) that has not responded to prior treatment. **You may be eligible if...** - You are at least 18 years old - You have advanced or metastatic bile duct cancer that cannot be surgically removed - Your cancer has progressed or you had side effects from one prior treatment - You have at least one measurable tumor on imaging - You are reasonably active (ECOG performance status 0, 1, or 2) - Your life expectancy is at least 12 weeks - Your blood counts, liver, and kidney function meet minimum thresholds **You may NOT be eligible if...** - You have not yet tried any systemic treatment for your cancer - You have uncontrolled infections or major bleeding - You are on blood-thinning medications that cannot be safely stopped - You are pregnant or breastfeeding - You have active autoimmune disease 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

DRUGCamrelizumab

a PD-1 immune check inhibitor

COMBINATION_PRODUCTUS/CT-guided Percutaneous Cryoablation

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT04299581


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