Cholangiocarcinoma
Conditions
Interventions
Camrelizumab combined with capecitabine group:Camrelizumab: medication once every 3 weeks
capecitabine tablets: taking 14 consecutive days, stopping the drug for 7 days, 21 days as a treatment cycle
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have been clinically diagnosed as hilar cholangiocarcinoma and completed portal vein embolization; 2. Preoperative assessment is expected to complete radical surgical resection; 3. Aged 18 to 80 years old, ECOG stamina score 0-1; 4. Liver function: total bilirubin 1.5x10^9/L, platelets>75x10^9/L; 6. Sufficient kidney reserve: creatinine <130 umol/L; 7. No cardiac insufficiency, chest pain (not medically controllable), and no myocardial infarction occurred within 12 months before the start of the study; 8. Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Past application of PD-1 inhibitors; 2. Past history of tumors in other systems; 3. Severe heart, brain, lung, kidney and blood system diseases; 4. Existence of distant metastasis or preoperative evaluation as local unresectable; 5. Those who have experienced arterial and venous thrombosis within 6 months before enrollment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism; 6. Pregnant or breastfeeding women; 7. Those who are participating in other clinical trials; 8. History of allogeneic organ transplantation; 9. People with known or suspected history of allergies to biological agents, allergic constitution, or allergic conditions; 10. Bleeding events, unhealed wounds, ulcers or fractures in any part of CTCAE Grade 3 or higher 4 weeks before medication; 11. Untreated intestinal obstruction that cannot eat or affects systemic administration; 12. HIV infection or AIDS-related diseases; 13. Inflammatory infections that receive planned treatment during the active infection period 14. According to the judgment of the investigator, patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study 15. Those who have a history of mental illness or abnormal behavior, etc., which the investigator judges are not suitable for participating in clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;ORR;mpRR;RFS;OS; | — |
Countries
China
Contacts
Public ContactZhang Yongjie
Shanghai Hengrui Pharmaceutical Co., Ltd.
Outcome results
None listed