Cholangiocarcinoma (CCA)
Conditions
Interventions
Dual-path chemotherapy group:Pembrolizumab:
200mg, IVGTT every 3 weeks. Treatment should be continued until the patient fails to achieve clinical benefit or develops intolerable toxicity. If the patie
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of subjects: 18-75 years old, male or female; 2. ICCA diagnosis confirmed by imaging and histopathology; 3. According to the CSCO Guidelines for the Diagnosis and Treatment of Biliary Tract Malignancies (2023 Edition), assessed as unresectable intrahepatic cholangiocellular carcinoma; 4. Laboratory values must meet the following criteria within 7 days before starting treatment: a) Neutrophil >=1.5×10^9/L; b) Platelet >=75×10^9/L; c) Hemoglobin >=90g/L (no concentrated red blood cells transfusion within 2 weeks); d) Serum creatinine =50ml/min (creatinine clearance is estimated based on the Cockcroft-Gault formula); e) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =30g/L; g) Patients who are not receiving anticoagulant therapy: INR or aPTT 3 months; 6. Confirmed presence of at least one measurable lesion based on RECIST1.1 criteria; 7. Physical status (PS) score of 0-1 in the Eastern United States Cooperative Oncology Group (ECOG) within 7 days before the first dose of study drug; 8. The subject has normal organ function, such as thyroid function, pituitary function, bone marrow function, etc.; 9. Patients suitable for interventional therapy; 10. Subject (or legal representative, if applicable) willing to sign an informed consent form to participate in the study; 11. Willing and able to comply with the study protocols and visit schedule.
Exclusion criteria
Exclusion criteria: 1. Esophageal or gastric variceal bleeding within the past 6 months. 2. Contraindications to interventional treatment, such as severe cirrhosis, moderate ascites, and liver function Child C grade. 3. Patients who refuse or are not suitable for interventional treatment. 4. Previous surgery, intervention, radiotherapy, systemic chemotherapy, targeted therapy, anti-PD-1 and anti-PD-L1 antibodies, and CAR-T and other immunotherapy. 5. Known to have another malignancy that is currently progressing or has required active treatment within the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast cancer, cervical cancer in situ) who have received potentially curative therapy are allowed. 6. Serious dysfunction of important organs such as heart, brain, and lungs. 7. Uncontrollable high blood pressure, gastrointestinal bleeding or coagulation dysfunction, etc. 8. Severe allergy to the study intervention and/or any of its excipients (= grade 3). 9. Pregnant or lactating, or planning to become pregnant or father during the study, i.e., from the screening visit until 120 days after the last dose of trial treatment. 10. History of disease or evidence of disease, abnormal treatment or laboratory values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or in the opinion of the investigator is not in the best interest of the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Security;Overall survival;Objective response rate; | — |
Countries
China
Contacts
Public ContactZheng Lin
Henan Cancer Hospital
Outcome results
None listed