Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gemcitabine combined with cisplatin or oxaliplatin, Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
Overview
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
- 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) - 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)
Primary outcome measures
- Overall survival (OS) [Time frame: 1 year]
Secondary outcome measures (1)
- Progression-free survival (PFS) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT06718257 · 2024-1058