intrahepatic cholangiocarcinoma
Conditions
Interventions
Intervention group: Peg-IFNa2b combined with pembrolizumab and GP
Sponsors
Zhongshan Hospital Fudan University Xiamen Branch
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–75 years, regardless of gender; voluntary participation with signed informed consent. 2. Diagnosis: Histologically confirmed intrahepatic cholangiocarcinoma deemed unresectable by the investigator. 3. Measurable Disease: At least one measurable lesion per RECIST 1.1 criteria. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 at baseline. 5. Life Expectancy: >3 months. 6. Adequate Organ Function (assessed within 7 days prior to treatment initiation): (1) Hematologic:Absolute neutrophil count >=1.5×10?/L;Platelet count =100×10?/L;Hemoglobin >=90 g/L (2) Renal:Serum creatinine =60 mL/min (calculated via Cockcroft-Gault formula) (3) Hepatic:Total bilirubin 1.5×ULN, direct bilirubin must be <=ULN); AST/ALT <=3×ULN (<=5×ULN if liver metastases present); (4) Coagulation:INR/PT/APTT <=1.5×ULN (if on anticoagulants, values within therapeutic range are acceptable). 7. Contraception: Women of childbearing potential must have a negative pregnancy test within 1 week prior to treatment and agree to use effective contraception during the study and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Prior systemic therapy for cholangiocarcinoma (e.g., TACE, surgery, or investigational drugs within 4 weeks). 2.Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids, immunosuppressants) within the past 2 years (exceptions: hormone replacement therapy for thyroid/adrenal/pituitary dysfunction). 3.Major surgery within 4 weeks with incomplete recovery or unresolved complications. 4.Prior therapy with anti-PD-1/PD-L1/PD-L2 agents or CTLA-4 inhibitors. 5.Live vaccination within 30 days prior to enrollment (e.g., measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, typhoid). 6.Immunodeficiency or chronic systemic steroid therapy (>10 mg prednisone equivalent/day) or other immunosuppressive therapy. 7.Active second malignancy requiring treatment within the past 3 years (exceptions: non-melanoma skin cancer or carcinoma in situ). 8.Severe hypersensitivity (=Grade 3) to Peg-IFNa2b, pembrolizumab, gemcitabine, cisplatin, or excipients. 9.History of steroid-requiring (non-infectious) pneumonitis or current pneumonitis. 10.Uncontrolled severe infection within 4 weeks. 11.Active HIV, tuberculosis, HBV, or HCV infection. 12.Known CNS metastases or carcinomatous meningitis. 13.Severe psychiatric disorders (e.g., major depression). 14.Unstable/uncontrolled cardiac disease within 6 months. 15.Other conditions deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity and incidence of AE and ADR; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactZhang Boheng
Zhongshan Hospital Fudan University Xiamen Branch
Outcome results
None listed