Intrahepatic Cholangiocarcinoma
Conditions
Brief 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
Interventions
DRUGTislelizumab combined with S-1
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.
Sponsors
Anhui Provincial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year RFS rate | 12 months | Proportion of patients with no local, regional, or metastatic ICC or death from any cause (whichever occurs first) 12 months after hepatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 24 months | Time from hepatectomy to the first documented occurrence of local, regional, or metastatic ICC or death from any cause, whichever occurs first. |
| OS | 24 months | Time from hepatectomy to first recorded occurrence of death from any cause |
| Survival time after recurrence | 24 months | The time from the first documented occurrence of localized, regional, or metastatic ICC, whichever occurs first, to death from any cause. |
| AEs AEs AEs AEs AE | 24 months | Adverse Events (AEs)The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 |
Countries
China
Contacts
Primary ContactJi-Zhou Wang
Outcome results
None listed