Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria: 1) Volunteer to take part in the study ; 2) Age ≥65 , male or female; 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; 4) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered. 5) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable; 6) At least one assessable lesion (RECIST 1.1 ); 7) Expected survival time ≥ 6 months; 8) ECOG 0-2; 9) If the main organs function normally, they meet the following standards: Blood routine examination (no blood transfusion and G-CSF use within 14 days before screening): Hemoglobin ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; White blood cell count ≥ 3.0 × 109/L; Platelet count ≥ 80 × 109/L; Blood biochemical examination (albumin was not used within 14 days before screening): Albumin ≥ 28 g/L; Total bilirubin ≤ 2 × Upper limit of normal value (ULN); In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN; ALT, AST and ALP ≤ 5× ULN in case of liver metastasis ; Alkaline phosphatase (ALP) ≤ 5 × ULN; Creatinine ≤ 1.5 × ULN; Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; j) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。 Exclusion Criteria: 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases: The patient has received possible curative treatment and there is no evidence of the disease within 5 years; The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received; 2) Have received allogeneic stem cells or solid organ transplantation in the past; 3) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation); 4) Previous or current congenital or acquired immunodeficiency disease; 5) Allergic to the study drug; 6) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation; 7) Serious infection in active period or poorly controlled clinically; 8) Not recovered from the operation; 9) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures; 10) Other situations that the investigator thinks are not suitable for inclusion.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Disitamab Vedotin Combined With Sintilimab
Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.