A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for P… (NCT05967182) | Clinical Trial Compass
RecruitingPhase 2
A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma
United States24 participantsStarted 2024-01-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Provision of signed Informed Consent prior to any screening procedures being performed.
✓. Age ≥ 18 years at the time of informed consent.
✓. Histologically (or cytologically) confirmed diagnosis of intrahepatic cholangiocarcinoma or adenocarcinoma of suspected biliary origin/ cholangiocarcinoma that is measurable according to RECIST 1.1 criteria.
✓. 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):
✓. T-stage ≥ Ib (Ib - IIIb)
✓. Solitary lesion \> 5 cm
✓. Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
✓. Presence of major vascular invasion but still technically resectable
Exclusion criteria
✕5. Ability to understand and the willingness to sign a written informed consent document.
✕6. English and non-English-speaking patients.
✕7. HIV-infected participants must have well-controlled HIV on ART, defined as:
✕
What they're measuring
1
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Timeframe: through study completion; an average of 1 year
. 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).
✕. Has had previous systemic therapy for ICC.
✕. Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasm.
✕. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
✕. Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy.