Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Two cycles of HAIC_GC treatment will be administered. Meanwhile, the PDL1 inhibitor combined with capecitabine will be given on a 21-day cycle for up to eight cycles. After the comp
gemcitabine 1000mg/m2 on the first day, with arterial infusion for half an hour. Repeat every 3 weeks for 2 cycles of treatment.
2) Eight cycles of capecitabine: 1250 mg/m2, taken orally, twice a day,
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed ICC 2. Previously underwent curative-intent surgical resection 3. Aged 18 to 75 years, regardless of gender 4. ECOG performance status 0 or 1 5. Expected life expectancy of >= 3 months 6. Confirm the absence of extrahepatic spread and tumor recurrence through CT or MRI scans of the chest, abdomen, pelvis, and head. 7. Between 2 and 12 weeks after resection. Have recovered to a fully rehabilitated state from surgical resection: adequate wound healing after the operation, with the surgical drain removed. 8. Adequate oral intake. 9. Adequate renal functions: as follows: serum creatine= 60 ml/min. 10. Adequate haematological function: neutrophil count >= 1.5×10^9/L; hemoglobin >= 80g/L; platelet count >= 60×10^9/L; WBC >= 3.0 x 10^9/L 11. Adequate liver function: serum albumin>= 28g/L; total bilirubin<3-times ULN; ALT<5-times ULN; AST<5-times ULN; 12. The Child-Pugh score is between 5 and 7. 13. Voluntarily participate and sign an informed consent.
Exclusion criteria
Exclusion criteria: 1. Known history of other malignancy within 5 years of trial entry, except adequately treated cervical carcinoma-in-situ or non-melanotic skin cancer. 2. Use of iodine and gadolinium contraindicated due to allergic to contrast agents. 3. Abnormalities of the hepatic artery prevent the implementation of HAIC. 4. Pregnant or lactating women, unwillingness to use contraceptive measures in males and females. 5. Previous treatment with immunotherapy, for instance anti-PD-1, anti-PD-L1, anti-PD-L2, or any other T-cell co-stimulation or checkpoint inhibitor therapy. 6. A history of gastrointestinal bleeding within 3 months prior to enrollment. 7. A history of arterial and venous thrombotic events within 6 months prior to enrollment, such as myocardial infarction, cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism. 8. A history of psychotropic drug abuse or drug abuse. 9. Underwent organ transplantation before. 10. Hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc. 11. be allergic to related drugs. 12. Any previous chemotherapy or immunotherapy, given for ICC. 13. Any serious uncontrolled medical conditions likely to interfere with protocol treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;time to recurrence;safety; | — |
Countries
China
Contacts
Public ContactHong Wu
West China Hospital, Sichuan University
Outcome results
None listed