malignant tumor of digestive tract
Conditions
Interventions
experimental group:The dosage of carrillizumab was 200mg, administered by intravenous infusion, each infusion was 30 min (not less than 20 min, not more than 60 min), Q2W/Q3W
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:18-75 years old (calculated on the date of signing informed consent); gender unlimited; 2. Patients with advanced gastrointestinal cancer (including liver cancer, gastric cancer, esophageal cancer) confirmed by histopathology and / or cytology; 3. At least one measurable lesion exists in CT / MRI according to the recist1.1 standard; 4. ECoG PS score 0-2; 5. It is planned to use carrizumab for single drug treatment or combined with other treatment; 6. Subjects voluntarily join the study, sign informed consent, have good compliance, cooperate with visit; 7. Main organs function is normal, and meet the following standards: (1) routine blood test: (a) hemoglobin (HB) >= 90 g / L; (b) leukocyte (ANC) >= 1.5 x 10^9 / L; (c) platelet (PLT) >= 60 x 10^9 / L; (2) biochemical examination: (a) ALB >= 29 g / L; (b) ALT and AST < 5 ULN; TBIL <= 50umol / L; creatinine <=1.5ULN.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. have been confirmed to be allergic to carrizumab and / or its adjuvants; 3. have any active autoimmune disease or a history of autoimmune disease; 4. have received hematopoietic stem cells or any organ transplantation; 5. have had severe allergic reaction to other monoclonal antibodies; 6. have severe hepatorenal insufficiency (Level 4); 7. According to the judgment of the researchers, there are serious hazards to the patient's safety or accompanying diseases that affect the patient's completion of the study; 8. Patients who are participating in clinical trials of other drugs; 9. The estimated survival time is less than 3 months; 10. Patients who have mental illness or history of mental drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactJie Ma
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed