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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tislelizumab
DrugTislelizumab plus chemotherapy (14 days as one cycle) 3 cycles every 2 weeks as neoadjuvant therapy and followed by a curative surgery. Tislelizumab 200 mg fixed-dose IVD on day 1. Gemcitabine 800 mg/m2 on day 1 with a fixed-infusion rate of 80 mins. Cisplatin 25 mg/m2 on day 1. S-1 70 mg/m2 daily as a BID dosing per oral on day 1 to 7. (daily total dose determined by body surface area (BSA): \<1.25 m2, 80 mg; 1.25-1.50 m2, 100 mg; ≥1.50 m2, 120 mg)
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Tislelizumab-Gemcitabine/Cisplatin/S-1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
R0 resection rate
Margin-free resection (R0) rate: (Number of patients with surgical results achieving an uninvolved margin under microscopic and macroscopic inspection) / (Number of patients receiving a surgery) x 100%
Time frame
From enrollment to surgical resection at 2 weeksSecondary outcomes
1
Objective response rate
Patients who achieve a complete or partial response as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
From enrollment to the end of neoadjuvant therapy at 2 weeks2
Overall survival
The time interval from enrollment to death by any causes
Time frame
From the date of enrollment until the date of death from any cause3
Event-free survival
The time interval from enrollment to an event, defined as disease progression, recurrence, withdrawal from trial treatment, initiation of subsequent anticancer treatment or death by any cause, in whichever happens first.
Time frame
From the date of enrollment until the date of any predefined event which happens first4
Disease control rate
Patients who achieve a complete response, partial response or stable disease, as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
From enrollment to the end of neoadjuvant therapy at 2 weeksOther outcomes
1
Protocol completion rate
Patients who complete the protocol neoadjuvant treatment / Enrolled patients X100%
Time frame
From enrollment to the end of neoadjuvant therapy at 2 weeks2
Adverse events related to protocol treatment
Patients who present with ≥grade III adverse events resulting from protocol treatment per National Cancer Institute- Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0).
Time frame
From enrollment to the end of neoadjuvant therapy at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cheng-Kung University Hospital
Lead sponsor
Kaohsiung Veterans General Hospital.
Collaborator
Chi Mei Medical Hospital
Collaborator
Source ClinicalTrials.gov
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