Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma

Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06718257

Enrollment

300

Registered

2024-12-05

Start date

2024-09-01

Completion date

2025-05-31

Last updated

2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Keywords

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

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.

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.

Interventions

DRUGGemcitabine 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)

DRUGGemcitabine 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)

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactWeilin Wang, PHD

wam@zju.edu.cn+86 057187783820

Backup ContactYuan Ding, PHD

dingyuan@zju.edu+86 18858101960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026