Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Gemcitabine 1000mg/m2 d1, d8 + cisplatin 25mg/m2 d1, d8, q3w + tislelizumab 200mg d1, q3w
Control group:Capecitabine 1250mg/m2 bid d1–14, q3w
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed intrahepatic cholangiocarcinoma having undergone curative-intent resection (R0 margin status). 2. Inclusion criteria consisted of individuals aged between 18 and 75 years, regardless of gender. 3. Participants with a predicted survival time of >= 12 weeks were eligible for enrollment. 4. Eastern Cooperative Oncology Group performance status (ECOG) score ranging from 0 to 1 was required. 5. No radiological evidence of postoperative recurrence or metastasis. 6. Presence of >= 1 high-risk recurrence factors: tumor size >= 5 cm, microvascular invasion, poor differentiation, or regional lymph node metastasis. 7. Eligible patients had not experienced any prior systemic anti-tumor therapy for intrahepatic cholangiocarcinoma. 8. Prior to study drug administration and within one week before enrollment: hemoglobin level should be >= 90g/L; platelet count >= 75×10^9/L; white blood cell count >= 3.0×10^9/L; neutrophil count >= 1.5×10^9/L; total bilirubin <= 1.5 times upper limit of normal; serum creatinine <= 1.5 times upper limit of normal; alanine aminotransferase and aspartate aminotransferase levels <= 2.5 times upper limit of normal. 9. Written informed consent was obtained from all participants who voluntarily agreed to participate in this study.
Exclusion criteria
Exclusion criteria: 1. A history of other malignancies with disease-free survival less than 5 years (excluding cured basal cell carcinoma of the skin, cured carcinoma in situ of the cervix, and gastrointestinal cancer proven cured by endoscopic mucosal resection). 2. Immunodeficiency disease or HIV infection. 3. Severe acute uncontrolled infection (infection causing fever above 38 °C). 4. History of active hepatitis B or active hepatitis C, with a hepatitis B virus (HBV) DNA titer test result >= 2000 IU/mL (or 1×10^4 copies/mL), and a hepatitis C virus (HCV) RNA test result >= detection limit. 5. Severe liver and kidney dysfunction; recent history of myocardial infarction within the past 3 months. 6. Subjects with an active or previous autoimmune disease or risk of relapse. However, subjects with type 1 diabetes, hypothyroidism requiring hormone-replacement therapy only, or skin conditions requiring no systemic treatment such as vitiligo, psoriasis, or alopecia were allowed. 7. History of interstitial lung disease or noninfectious pneumonia that may hinder evaluation or management of study-drug-related pulmonary toxicity due to symptomatic disease or previous pulmonary history. 8. Subjects with a history of active pulmonary tuberculosis infection within one year before the first dose of study drug were eligible for enrollment if they had a history more than one year prior without evidence of current active pulmonary tuberculosis as determined by the investigator. 9. Patients with chronic diarrhea lasting for an extended period or complete intestinal obstruction. 10. Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of the study drug. Note: In absence of active autoimmune disease. 11. Complicated with other serious medical or surgical diseases that affect organ function, and the investigator considers that they are not suitable for participating in the trial. 12. Participated in other clinical trials of new drugs within 4 weeks. 13. Pregnant or lactating women or patients of childbearing potential (men or women with menopause less than 1 year) who are unwilling to use contraception. 14. Subjects with a history of allergic or hypersensitive reactions to a study drug component. 15. Who were deemed by the investigator to be ineligible for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactYang Yu
West China Hospital, Sichuan University
Outcome results
None listed