gallbladder cancer
Conditions
Interventions
Group 1:pd-1 inhibitor
Group 2:tigio
Sponsors
Shanghai Oriental Hepatobilliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The histopathological diagnosis of gallbladder carcinoma was confirmed as tnm stage (ajcc8th) from IIIa stage to IVa stage; 2. Pathological examination confirmed r0 excision; 3. Aged from 18 to 75 years, ecog's physical strength score was 0 to 2; 4. Liver function grade child-pugh a; 5. The basic normal bone marrow function: neutrophil > 1.5 × 10 ~ 9uL, platelet > 75 × 10^9 uL; 6. Sufficient kidney reserve: creatinine < 130 umol/l; 7. Expected survival time = 3 months; 8. An informed consent was signed.
Exclusion criteria
Exclusion criteria: 1. Non-r0 resection was found in the middle of operation or postoperative pathology; 2. Pd-1 inhibitors have been used in the past; 3. Previous history of other systemic tumors, except: (1) carcinoma in situ; (2) treated basal cell carcinoma; (3) superficial bladder cancer (ta,tis and T1); (4) any cancer 4 that received radical treatment three years ago. Severe heart, brain, lung, kidney and blood system diseases; 5. The presence of brain or meningeal metastasis; 6. The time of venous thrombosis, such as cerebral vascular accident, deep venous thrombosis and pulmonary embolism, occurred within 6 months before admission to the group; 7. Pregnant or lactating women; 8. Participants in other clinical trials; 9. Have a history of allogeneic organ transplantation; 10. Known or suspected history of allergy to biological agents, anaphylaxis or being in anaphylaxis; 11. 4 weeks before treatment, bleeding occurred at any part of =CTCAE3 grade, with unhealed wounds, ulcers or fractures; 12. Unhandled intestinal obstruction that could not be feeded or administrated systemically; 13. HIV infection or aids-related diseases; 14. Inflammatory infections scheduled for active infection; 15. According to the researchers, patients with concomitant diseases that are likely to seriously endanger their own safety or may affect the completion of the study; 16. Having a history of mental illness or behavioral abnormalities; 17. with heart failure, chest pain (medically uncontrollable), myocardial infarction within 12 months before the start of the study; 18. the researchers determined that they were not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate; | — |
Contacts
Public ContactYongjie Zhang
Shanghai Oriental Hepatobilliary Surgery Hospital
Outcome results
None listed