MedTrace Logo

Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma

NCT05738057 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-11-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:

* Whether combined therapy using D-TACE, Gem/Cis, and PD-1 works well to convert unresectable ICC to resectable.
* Whether combined therapy using D-TACE, Gem/Cis, and PD-1 is safe. Participants will receive D-TACE (CalliSpheres with Gem 30 mg), camrelizumab (200 mg) plus gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2), and 24 months follow-up.

Conditions

  • Unresectable Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Camrelizumab

200mg on day1 of every 3 weeks, starting on day1 of cycle1

DRUG

Gemcitabine Injection

1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1

DRUG

Cisplatin injection

25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1

DRUG

Cisplatin-Eluting Beads

used for D-TACE

PROCEDURE

D-TACE

TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.

Sponsors & Collaborators

  • Hua Li

    lead OTHER

Principal Investigators

  • Yang Yang, MD&PhD · Third Affiliated Hospital, Sun Yat-Sen 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
2023-06-30
Primary Completion
2025-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

More Related Trials

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 NCT05738057 on ClinicalTrials.gov