Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma (NCT06903273) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma
Taiwan35 participantsStarted 2025-07-01
Plain-language summary
To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Image or histological evidence of hilar or portal lymph node involvement (N1).
✓. Initial serum cancer antigen-199 (CA199) ≥200 U/mL.
✓. Subjects present with at least one measurable lesion which can be accurately assessed by conventional techniques at least 1.0 cm by computed tomography (CT) or magnetic resonance imaging (MRI).
✓. Subjects are above 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, have a life expectancy \>3 months, have surgically resectable disease and are physically competent and willing to receive a curative operation following the study protocol
Exclusion criteria
✕. 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.
What they're measuring
1
R0 resection rate
Timeframe: From enrollment to surgical resection at 2 weeks
Trial details
NCT IDNCT06903273
SponsorNational Cheng-Kung University Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-07-01
Contact for this trial
Clinical Trial Center, National Cheng Kung University Hospital