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NOT YET RECRUITING
NCT06567600
PHASE2

Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma

Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1/PD-L1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma.

Official title: Combined Therapy Using Low-dose Gemcitabine and Cisplatin Chemotherapy and PD-1/PD-L1Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: an Open-label, Multicenter, Single-arm Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2024-09-01

Completion Date

2028-12-31

Last Updated

2024-08-22

Healthy Volunteers

No

Interventions

DRUG

Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody

Low-dose Gemcitabine and Cisplatin Chemotherapy: Gemcitabine 500 mg/m2 Cisplatin 12.5 mg/m2 on day 1 and day 8 of each 21-day cycle for up to eight cycles PD-1/PD-L1Antibody: Pembrolizumab 200mg on day 1 of each 21-day cycle Durvalumab 1500 mg on day 1 of each 21-day cycle After completion of gemcitabine and cisplatin, 200mg of Pembrolizumab or 1500 mg of Durvalumab may administer once every 3 or 4 weeks until clinical or imaging (per RECIST v1.1) disease progression or until unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria were met.

Locations (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China