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Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma.

NCT07147088 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-28

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of cryoablation combined with SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, plus famitinib, a multi-targeted receptor tyrosine kinase inhibitor, in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

Conditions

  • Advanced Intrahepatic Cholangiocarcinoma

Interventions

DRUG

SHR-1701

SHR-1701 will be administered by IV, 1200mg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

DRUG

Famitinib

Famitinib will be administered at 15 mg orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

PROCEDURE

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. SHR-1701 plus famitinib will be administered 1-3 days after cryoablation.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07147088 on ClinicalTrials.gov