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

Sponsor
Hua Li
Study ID
NCT05738057
Phase
PHASE2
Status
Unknown

Conditions

  • Unresectable Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    200mg on day1 of every 3 weeks, starting on day1 of cycle1
  • Gemcitabine Injection — DRUG
    1000mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
  • Cisplatin injection — DRUG
    25mg/m2 on day1 \& day8 of every 3 weeks, starting on day1 of cycle 1
  • Cisplatin-Eluting Beads — DRUG
    used for D-TACE
  • D-TACE — PROCEDURE
    TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary.

Study Details

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.

Key Dates

Start date
Jun 30, 2023
Status verified
Nov 2023
Primary completion
Mar 1, 2025
Completion
Mar 1, 2026

Study Design

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

Arms

  • Experimental: Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab
    D-TACE with cisplatin-eluting beads. More TACE can be done if clinically necessary. Camrelizumab (200 mg, Intravenous drips (ivd), D1/3W) plus Gem (1000 mg/m2, ivd, D1\&8/3W) and Cis (25 mg/m2, ivd, D1\&8/3W). Three weeks are one cycle of treatment. Chemotherapy lasted for no more than 12 cycles.

Primary Outcome Measure

Conversion rate [ Time Frame: 12 months ]

Central Contacts

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