Cholangiocarcinoma
Conditions
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18 to 75 years old; 2. ECOG score 0-1 points; 3. Adenocarcinoma of the biliary tract confirmed by histopathology or cytology (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer and ampullary cancer), refused or unable to undergo radical surgical resection, after a multidisciplinary discussion by the hepatobiliary surgeon Confirm that it cannot be resected or R0 resection cannot be achieved due to extensive vascular invasion; 4. The expected survival period is =3 months; 5. The main organs function normally, that is, they meet the following standards: (1) The standard of routine blood examination should meet: (no blood transfusion within 14 days) WBC =4.0×10^9/L; ANC =1.5×10^9/L; PLT =100×10^9/L; Hb =90g/L (2) The biochemical inspection shall meet the following standards: BIL 50ml/min (Cockcroft-Gault formula); 6. Before joining the group, the heart function was good, no myocardial infarction occurred within half a year, and hypertension and other coronary heart diseases are currently within the controllable range; 7. No other uncontrollable benign diseases, such as lung, kidney, liver infection, etc., were not accompanied before enrollment; 8. Subjects voluntarily join the study, have no mental illness or other psychiatric symptoms, have full capacity for civil conduct, have signed an informed consent form, have good compliance, and are able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. The subject has any active autoimmune disease; 3. The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 4. Those who have been confirmed to be allergic to carrelizumab, apatinib, fluorouracil, leucovorin, oxaliplatin and/or its excipients; 5. Researchers believe that patients with a clear gastrointestinal bleeding tendency or/and abnormal coagulation function (INR>1.5) have a bleeding tendency; 6. Those who have undergone other anti-cancer treatments two months before enrollment or cannot be guaranteed to follow the research requirements after enrollment; 7. Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication; 8. Pregnant or lactating women; 9. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactMa Liang
Affiliated Tumor Hospital of Guangxi Medical University
Outcome results
None listed