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

NCT06567600 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholangiocarcinoma
  • Chemotherapy Effect
  • Immunotherapy

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Ye Linsen, Professor · The third affiliated hospital of SYSU

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567600 on ClinicalTrials.gov