Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Drug: Gemcitabine combined with cisplatin or oxaliplatin; Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Weilin Wang, PHD; Phone Number: +86 057187783820; Email: wam@zju.edu.cn
• Study Contact Backup: Name: Yuan Ding, PHD; Phone Number: +86 18858101960; Email: dingyuan@zju.edu

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Weilin Wang, PHD; Phone Number: +86 057187783820; Email: wam@zju.edu.cn
      • Contact: Yuan Ding, PHD; Phone Number: +86 18858101960; Email: dingyuan@zju.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.

Description

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 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Patients initially received GP/GEMOX regimen.	Drug: Gemcitabine combined with cisplatin or oxaliplatin; Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)
Experimental group; Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.	Drug: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors; Gemcitabine (1000 mg/m², day 1 and 8), cisplatin (75 mg/m²; day 1) or oxaliplatin (85 mg/m²; day 1), PD-1/L1 agents (200 mg; day 1), and TKI inhibitors (8 mg; per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Progression-free survival (PFS) is defined as the time from the start of treatment until disease progression or the emergence of new lesions.	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Weilin Wang, PHD, Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: advanced cholangiocarcinoma; chemotherapy combined with immunotherapy and targeted therapy; clinical efficacy and safety
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Cholangiocarcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Oxaliplatin; Gemcitabine; Cisplatin
• Other Study ID Numbers: 2024-1058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No