Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

NCT06718257 | Recruiting DMC

• 1 other identifier: 2024-1058
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangiocarcinoma

Keywords

advanced cholangiocarcinoma; chemotherapy combined with immunotherapy and targeted therapy; clinical efficacy and safety

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.

  1 year

Secondary Outcomes (1)

• Progression-free survival (PFS)

  1 year

Study Arms (2)

Control group

Patients initially received GP/GEMOX regimen.

Drug: Gemcitabine combined with cisplatin or oxaliplatin

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

Interventions

Gemcitabine combined with cisplatin or oxaliplatin DRUG

Gemcitabine (1000 mg/m², day 1 and 8) and cisplatin (75 mg/m², day 1) or oxaliplatin (85 mg/m², day 1)

Control group

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

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)

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
• Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors

You may not qualify if:

• Direct surgery after hospitalization
• Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
• Initial treatment involving other comprehensive therapeutic regimens

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cisplatin; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Weilin Wang, PHD

  Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Weilin Wang, PHD

CONTACT

+86 057187783820; wam@zju.edu.cn

Yuan Ding, PHD

CONTACT

+86 18858101960; dingyuan@zju.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: September 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2024-11

Locations

CN (1)