Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cheng-Kung University Hospital
About this trial
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.
Eligibility criteria
Qualifiers
Solitary tumor with a maximal diameter ≥5 cm in the absence of vascular invasion.
≥T1b disease which is resectable.
Multifocal tumors or single tumor with satellite nodules at the same anatomic liver lobe which is/are resectable.
Tumor(s) with macroscopic intrahepatic vascular invasion but is/are potentially resectable.
Disqualifiers
Subjects have metastatic (M1) disease, recurrent cholangiocarcinoma which cannot be resected, recurrent cholangiocarcinoma which can be re-resected but occurs >6 months post previous surgery, or any other primary malignancies in which the subjects have been in disease-free status less than 2 years, excluding carcinoma in situ or resectable skin cancer.
Subjects have received a systemic therapy with either chemotherapeutics or immune checkpoint inhibitors, a major abdominal surgery or radiotherapy within 4 weeks before the trial enrollment.
Subjects are known to be severely allergic to any of the studied therapeutics.
Subjects have underlying chronic illnesses, including cardiopulmonary diseases, ischemic heart disease, inflammatory bowel disease, poorly-controlled diabetes mellitus, liver cirrhosis and/or debilitating autoimmune diseases or conditions.
Trial design
Treatments tested in this trial
- Tislelizumab
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
National Cheng-Kung University Hospital
Lead sponsor
Kaohsiung Veterans General Hospital.
Collaborator
Chi Mei Medical Hospital
Collaborator
Source ClinicalTrials.gov