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TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

NCT04954781 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-27

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Tislelizumab

Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

COMBINATION_PRODUCT

TACE

TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Peng Wang, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2025-07-15
Completion
2025-07-15

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 NCT04954781 on ClinicalTrials.gov