advanced intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:1. Tirelizumab: 200mg, q3w, intravenous drip, lasting for 1 year, or until the disease progresses or intolerable adverse reactions occur
2. Remvastinib: 8mg, qd, oral, until the disease progresses or intolerable adverse reactions occur
3. Capecitabine: 1000mg/m2, bid, oral, take it for 2 weeks, stop for 1 week
Sponsors
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Intrahepatic cholangiocarcinoma was confirmed by pathological or cytological diagnosis; 2. Have at least one measurable evaluable lesion according to RECIST 1.1 criteria; 3. Not suitable for GP chemotherapy (conforming to one or more of the following): (1) Older than 75 years; (2) ECOG 2-3; (3) Liver function classification Child-Pugh B (more than 7); (4) Poor bone marrow hematopoietic reserve: baseline white blood cells: = 3 months; 6. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously received systemic therapy, including chemotherapy, targeted therapy and immunotherapy; 2. Secondary malignancies or other tumors (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to the study; 3. There is brain parenchymal or meningeal metastasis; 4. Combined with diseases with abnormal immune function, such as rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc.; 5. Have a history of organ transplantation, such as kidney transplantation, liver transplantation, heart transplantation, etc.; 6. Patients who need long-term oral hormone therapy due to their underlying diseases; 7. Patients with interstitial pneumonia; 8. One of the following conditions is confirmed by gastroscopy: "red sign", moderate or above esophageal and gastric varices, digestive tract ulcers (active stage); 9. Patients with imaging evidence of tumor involvement of important blood vessels or who were assessed by the investigator to be at risk of fatal bleeding during follow-up; 10. Bleeding events at any site of >= CTCAE grade 3, unhealed wounds, ulcers or fractures occurred 4 weeks before medication; 11. Occurrence of arterial and venous thrombosis events such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before enrollment; 12. Untreated complete/incomplete ileus that prevents eating or affects systemic administration; 13. Active biliary tract infection or other inflammatory infections that may affect patients receiving antitumor therapy; 14. Poor renal function: creatinine > 176 µmol/L or eGFR < 30 mL/min/1.73m2; 15. People with a history of substance abuse or mental disorders that are difficult to control; 16. Patients with concomitant diseases that, in the judgment of the investigator, may seriously endanger their own safety or may interfere with the completion of the study; 17. Participated in other clinical trials; 18. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-month Progression Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate (DCR);Progression-free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactYuan Zhengang
The Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital)
Outcome results
None listed