Envafolimab Combined With GEMOX in First-line Treatment of Advanced GBC
Gallbladder Cancer
![Eastern Hepatobiliary Surgery Hospital](https://trials-media.s3.amazonaws.com/orgs/eastern-hepatobiliary-surgery-hospital.jpeg)
About this trial
This is an interventional treatment trial for Gallbladder Cancer focused on measuring Envafolimab(immune checkpoint inhibitor anti-PD-L1 antibody)
Eligibility Criteria
Inclusion Criteria: Definite diagnosis of gallbladder carcinoma by histology or cytology; There is at least one measurable lesion (according to RECIST1.1); From 18 to 75 years old, ECOG physical strength score of 0-2; Basically normal bone marrow function: neutrophils >1.5x10^9/L, platelets >100x10^9/L; Adequate renal function: creatinine clearance > 60ml/min; Adequate liver function: bilirubin ≤1.5ULN; No cardiac insufficiency or chest pain (medically uncontrollable); No myocardial infarction in the 12 months prior to study initiation; Estimated survival time ≥3 months; The patient must sign an informed consent form. Exclusion Criteria: Previous systematic therapy, including chemotherapy, immunotherapy and targeted therapy; Secondary malignancies or other neoplasms (except superficial skin cancer and localized low-grade malignancies) occurring in the 3 years prior to study initiation; The presence of brain or meningeal metastasis; Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc. ); Have received allogeneic organ transplantation (eg kidney transplantation, liver transplantation, heart transplantation, etc. ); Patients who need long-term oral hormone therapy due to their underlying diseases; Patients with interstitial pneumonia and autoimmune hepatitis; Inflammatory infections during the active period of infection or other patients who may have disabilities receive planned treatment; Persons with a history of uncontrolled substance abuse or mental disorders; Patients with concomitant diseases that, in the judgment of the investigator, may seriously endanger their own safety or may interfere with the completion of the study; Patients with poor renal function; Untreated complete/incomplete ileus that prevents eating or interferes with systemic administration; Participated in other clinical trials; Pregnant and lactating women.
Sites / Locations
- Easter hepatobiliary surgery hospitalRecruiting
Arms of the Study
Arm 1
Experimental
Envafolimab+Gemox