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Trial Title:
Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma
NCT ID:
NCT06664021
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab combined with S-1
Description:
Tislelizumab：200mg q3w iv , lasts for one year. S-1：40mg, 50mg, or 60mg orally twice
daily for 4 weeks, depending on body surface area, followed by 2 weeks of rest，lasts four
cycles.
Arm group label:
Treatment group
Summary:
Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1
in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical
surgery
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-75 years old, male and female;
- Intrahepatic cholangiocarcinoma was pathologically confirmed after R0 or R1
resection. Patients were also pathologically confirmed to have one of the following
high-risk factors (i.e., positive margins, multiple tumor nodes, positive lymph
nodes, positive perineural infiltration, intrahepatic cholangiocarcinoma >5 cm in
diameter, and combined vascular invasion);
- Enhanced computed tomography (CT) scans of the chest, abdomen, and pelvis were
required within 30 days prior to surgery to demonstrate the absence of distant tumor
metastases;
- No history of any chemotherapy, radiotherapy, immunotherapy or interventional
therapy within 3 months prior to surgical resection;
- Child-Pugh grade A or B, ECOG score 0-1;
- Normal organ function prior to drug administration: ANC ≥1.5×10^9/L, Hemoglobin
≥90g/L, PLT >50*10^9/L, serum creatinine (SCr) ≤ 1.5 times the upper limit of normal
(ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); total bilirubin
(TBIL) ≤2 times the upper limit of normal (ULN); glutamine transaminase (AST) or
glutamine transaminase (ALT) levels ≤3 times the ULN; urinary protein <2+ (if
urinary protein) upper limit of normal (ULN); albumin transaminase (AST) or alanine
transaminase (ALT) levels ≤3 times upper limit of normal (ULN); urine protein <2+
(if urine protein ≥2+, 24-hour urine protein quantification must show ≤1g of
protein); and adequate surgical biliary drainage with no signs of infection.
- Normal coagulation function: a. International normalized ratio INR ≤ 1.5 x ULN; b.
Partial thromboplastin time APTT ≤ 1.5 x ULN; c. Prothrombin time PT ≤ 1.5 ULN;
- In case of hepatitis B virus (HBV) infection: if HBsAg-positive, HBV-DNA testing is
required and HBV-DNA must be <2000 IU/mL and willing to receive antiviral therapy
throughout the study period; hepatitis C virus (HCV)-RNA-positive patients must have
HCV-RNA <1×10^3copy/mL and must receive antiviral therapy according to treatment
guidelines.
- No major abnormalities in heart, lung or kidney function;
- No history of gastrointestinal hemorrhage;
- Sign the informed consent form.
Exclusion Criteria:
- The tumor is not completely resected, or the pathological diagnosis suggests
non-intrahepatic cholangiocarcinoma such as hepatocellular carcinoma, mixed
hepatocellular carcinoma, and hepatoportal cholangiocarcinoma;
- Pregnant or breastfeeding women;
- Combined with other malignant tumors;
- Have any active autoimmune disease or a history of autoimmune disease;
- Uncontrolled clinically significant cardiac disease, including but not limited to
the following: (1) > NYHA II congestive heart failure; (2) unstable angina pectoris;
(3) myocardial infarction within the last 1 year; (4) clinically significant
supraventricular arrhythmia or ventricular arrhythmia requiring treatment or
intervention;
- The patient has a congenital or acquired immunodeficiency;
- Uncontrollable infection > grade 2 (NCI-CTC version 5.0);
- Psychopaths;
- Patients have participated in other clinical trials within the past three months;
- Postoperative patients receiving other targeted agents, immunotherapy such as PD-1
antibodies, and FOLFOX systemic chemotherapy;
- Patients who are not suitable to participate in the study as determined by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
No.2 People's Hospital of Fuyang city
Address:
City:
Fuyang
Zip:
236015
Country:
China
Status:
Recruiting
Contact:
Last name:
DaYong Luo
Phone:
13805587172
Email:
fyldy7172@sina.com
Facility:
Name:
Anhui province hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ji-Zhou Wang, M.D.
Phone:
+86 13836135864
Email:
wangjoe@ustc.edu.cn
Start date:
November 10, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06664021
