Actively Recruiting
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
24
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any screening procedures
- Age 18 years or older at consent
- Confirmed intrahepatic cholangiocarcinoma or suspected biliary adenocarcinoma measurable by RECIST 1.1
- High-risk but resectable tumor confined to liver, bile duct, or regional lymph nodes with specific imaging criteria
- ECOG performance status 0 or 1
- Adequate blood counts and liver function within defined limits
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
- Controlled hepatitis B or C infection if present
- Willingness and ability to comply with study requirements
- Prior or concurrent malignancies allowed if unlikely to interfere with study
- Agreement to use adequate contraception if of child-bearing potential
- Ability to understand and sign informed consent
- HIV-infected participants must have well-controlled HIV on stable ART with CD4+ count ≥ 350 cells/mm3 and undetectable viral load
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, or other T-cell receptor agents
- Previous systemic therapy for intrahepatic cholangiocarcinoma
- Small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed histology, or mucinous cystic neoplasm
- Systemic anti-cancer therapy within 4 weeks before study
- Uncontrolled serious illnesses including recent heart conditions
- Active uncontrolled infections requiring systemic treatment
- Radiotherapy within 2 weeks before study intervention
- Live vaccines within 30 days before first dose
- Participation in other investigational studies within 4 weeks
- Immunodeficiency or recent immunosuppressive therapy
- Active malignancies requiring treatment within 2 years except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab
- Active autoimmune disease requiring recent systemic treatment
- History or current lung disease requiring steroids
- Active infection needing systemic therapy
- Concurrent active hepatitis B or C infection
- Conditions or treatments interfering with study participation
- Psychiatric or substance abuse disorders impacting cooperation
- Pregnancy or breastfeeding or planning conception during study
- Prior allogenic tissue or organ transplant
- Cognitive impairment
- HIV-infected participants with Kaposi's sarcoma or Multicentric Castleman's Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Hop Tran Cao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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