A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05967182
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Given by IV (vein)
  • Gemcitabine — DRUG
    Given by IV (vein)
  • Cisplatin — DRUG
    Given by IV (vein)

Study Details

To find out if adding pembrolizumab to standard of care chemotherapy drugs (cisplatin and gemcitabine) will improve long-term response of intrahepatic cholangiocarcinoma after surgery, compared to treatment with surgery and standard chemotherapy alone.

Key Dates

Start date
Jan 16, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab with Gemcitabine and Cisplatin
    Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Hop Tran Cao, MD
[email protected]
713-745-4670
Hop Tran Cao, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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