Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma

NCT06664021 | Recruiting Phase 2 DMC

• 1 other identifier: 2024KY467
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year RFS rate

  Proportion of patients with no local, regional, or metastatic ICC or death from any cause (whichever occurs first) 12 months after hepatectomy.

  12 months

Secondary Outcomes (4)

• RFS

  24 months

• OS

  24 months

• Survival time after recurrence

  24 months

• AEs AEs AEs AEs AE

  24 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Tislelizumab + S-1

Drug: Tislelizumab combined with S-1

No treatment group

NO INTERVENTION

No postoperative adjuvant therapy is performed

Interventions

Tislelizumab combined with S-1 DRUG

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.

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (2)

No.2 People's Hospital of Fuyang city

Fuyang, Anhui, 236015, China

RECRUITING

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Lian-xin Liu

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-Zhou Wang

CONTACT

+86 13836135864; wangjoe@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 29, 2024
• Study Start: November 16, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)