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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Intrahepatic CholangiocarcinomaChemotherapy EffectImmunotherapy
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."

Trial Locations (1)

Unknown

The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou

All Listed Sponsors
collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

lead

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

NCT06567600 - Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma | Biotech Hunter | Biotech Hunter