intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:HAIC-GEMOX+Immunotherapy+Targeted Therapy
Experimental group:Gemcitabine combined with oxaliplatin hepatic arterial infusion chemotherapy
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age range of the research subjects was limited to between 18 and 75 years old; 2. The inclusion criteria were intrahepatic cholangiocarcinoma (ICC) diagnosed by histopathology or cytology, accompanied by lymph node metastasis; 3. The research subjects had no history of receiving chemotherapy or immunotherapy before enrollment; 4. The ECOG score was between 0 and 1 within 2 weeks before enrollment; 5. The expected survival period exceeds 3 months; 6. The liver, kidneys and blood function reserves are sufficient; 7. Female subjects of childbearing age must complete a serum pregnancy test within 14 days before the start of the study treatment, with a negative result, and be willing to take reliable contraceptive measures during the study and within 60 days after the last administration of the study drug; 8. Male subjects whose partners are women of childbearing age should agree to take reliable contraceptive measures during the study period and within 120 days after the last administration of the study drug; 9. The subjects voluntarily participated in this study, signed the informed consent form, had good compliance, and were willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Other active malignant tumors except for intrahepatic cholangiocarcinoma in pregnant and lactating women. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, are not within this exclusion scope. 2. Patients with distant intracranial metastases (excluding intrahepatic metastases, hilar lymph node metastases, distant lymph node metastases, gastric, diaphragm, pancreatic head and colon invasions/pulmonary metastases/bone metastases, etc. 3. Patients who have received other systemic treatments have been desensitized for more than 3 months; 4. Patients whose biliary obstruction has not been relieved; 5. Patients with major cardiovascular and cerebrovascular diseases (such as New York Heart Association Grade II or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmias or angina pectoris, or LVEF (left ventricular ejection fraction) 10mg prednisone per day) or any other form of immunosuppressive therapy for a long time. Subjects using inhaled or topical corticosteroids can be enrolled; 11. It is known that the subjects were previously allergic to large molecule protein preparations, or any drug components or excipients of PD-1 inhibitors and GEMOX; 12. Patients with active infection, fever of unknown cause (>=38.5°C) or baseline white blood cell count > 15×10^9/L within three days before administration; 13. Patients with grade III or above bone marrow suppression (white blood cells lower than 1.9×10^9/L, hemoglobin lower than 79g/L, platelets lower than 49×10^9/L); 14. Patients with severe liver dysfunction, serum albumin lower than 28g/L, or serum direct bilirubin greater than 3mg/dL; 15. Patients positive for human immunodeficiency virus (HIV, HIV 1/2 antibody); 16. Patients who used strong CYP3A4/CYP2C1 inducers including rifampicin (and its analogues) and Forsythia suspensa or strong CYP3A4/CYP2C19 inhibitors within 14 days before enrollment; 17. Patients who have received or are about to receive live vaccines within 30 days before the administration of PD-1 inhibitors; 18. Patients with a history of psychotropic drug abuse, alcoholism or drug abuse; 19. Other factors that may affect the safety of the subjects or the compliance of the study as judged by the researchers. Patients with serious diseases that require concurrent treatment (including mental disorders), or other family or social factors with a history of drug abuse, alcoholism or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1year Overall Survival?2 years Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival(RFS);Disease-free survival,DFS;Major Pathological response,MPR;DCR;Incidence of adverse reactions;Progression-free survival;pathologic complete response, pCR; | — |
Countries
China
Contacts
Public ContactShi Xiangde
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed