Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Last updated: February 5, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Biliary Tract Cancer

Liver Cancer

Digestive System Neoplasms

Treatment

Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors

Gemcitabine combined with cisplatin or oxaliplatin

Clinical Study ID

NCT06718257
2024-1058
  • Ages > 18
  • All Genders

Study Summary

This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or radiologically confirmed intrahepatic cholangiocarcinoma

  • Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors

Exclusion

Exclusion Criteria:

  • Direct surgery after hospitalization

  • Initial treatment combined with local therapies (radiotherapy, radiofrequency,particle implantation, TACE, etc.)

  • Initial treatment involving other comprehensive therapeutic regimens

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
May 31, 2025

Study Description

This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.

Connect with a study center

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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