NCT06664021 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Intrahepatic Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-16 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-11-16 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Lian-xin Liu
PRINCIPAL INVESTIGATOR
Anhui Provincial Hospital
Frequently Asked Questions
Who can join the NCT06664021 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Intrahepatic Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06664021 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06664021 currently recruiting?
Yes, NCT06664021 is actively recruiting participants. Contact the research team at wangjoe@ustc.edu.cn for enrollment information.
Where is the NCT06664021 trial being conducted?
This trial is being conducted at Fuyang, China, Hefei, China.
Who is sponsoring the NCT06664021 clinical trial?
NCT06664021 is sponsored by Anhui Provincial Hospital. The principal investigator is Lian-xin Liu at Anhui Provincial Hospital. The trial plans to enroll 60 participants.