RecruitingCholangiocarcinoma
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ Participants are eligible to be included in the study only if all of the following criteria apply:
- ✓ 1. Provision of signed Informed Consent prior to any screening procedures being performed.
- ✓ 2. Age ≥ 18 years at the time of informed consent.
- ✓ 3. Histologically (or cytologically) confirmed diagnosis of intrahepatic cholangiocarcinoma or adenocarcinoma of suspected biliary origin/ cholangiocarcinoma that is measurable according to RECIST 1.1 criteria.
- ✓ a) Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- ✓ 4. Has high-risk, but resectable, ICC confined to the liver, bile duct, and /or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan done within 6 weeks of screening show at least one of the following (a-e):
- ✓ 1. T-stage ≥ Ib (Ib - IIIb)
- ✓ 2. Solitary lesion \> 5 cm
You may not qualify if…
- ✕ Participants are excluded from the study if any of the following criteria apply:
- ✕ 1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
- ✕ 2. Has had previous systemic therapy for ICC.
- ✕ 3. Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasm.
- ✕ 4. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- ✕ 5. Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy.
- ✕ 6. Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- ✕ 7. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT05967182 · last updated 2026-10-07