unresectable locally advanced or advanced gastric cancer
Conditions
Interventions
Experimental group:Distamab Vedotin combined with PD-1 and chemotherapy
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary participation and signing of an informed consent form in writing; 2) Age between 18 to 70 years old (inclusive of 70 years old), no gender restriction; 3) Histologically and/or cytologically confirmed unresectable locally advanced or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction; 4) No prior systemic treatment; 5) HER2 immunohistochemistry (IHC) test results are IHC3+, 2+, or 1+, and the subject's previous test results (confirmed by the researcher), and research center results are acceptable; 6) Having a single initial unresectable factor; 7) Having at least one evaluable lesion (RECIST V1.1 criteria); 8) Expected survival time is =6 months; 9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1; 10) Normal major organ function, that is, meeting the following criteria: Blood routine examination (within 14 days before screening, no blood transfusion and no use of G-CSF): a) Hemoglobin =90g/L; b) Absolute neutrophil count (ANC) =1.5×10^9/L; c) White blood cell count =3.0×10^9/L; d) Platelet count =80×10^9/L; Blood biochemical examination (within 14 days before screening, no use of albumin): e) Albumin =28g/L; f) Total bilirubin =2×upper limit of normal (ULN); g) In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =2.5×ULN; in the presence of liver metastasis, ALT, AST, and ALP =5×ULN; h) Creatinine =1.5×ULN; i) International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 times the Upper Limit of Normal (ULN); j) Activated Partial Thromboplastin Time (APTT) =1.5 times the Upper Limit of Normal (ULN).
Exclusion criteria
Exclusion criteria: 1) History of malignant tumors other than gastric cancer, except for the following two situations: a) The patient has received potentially curative treatment and there is no evidence of the disease within 5 years; b) Successfully received excision for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and other in situ carcinomas; 2) Suffer from diseases that affect the absorption, distribution, metabolism, or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 3) History of allogeneic stem cell or solid organ transplantation; 4) History of other systemic antitumor treatments (including traditional Chinese medicine with antitumor indications), less than 4 weeks from the completion of treatment to the start of medication in this study, or patients with adverse events from previous treatments that have not recovered to =CTCAE grade 1 (except for alopecia and pigmentation); 5) History of congenital or acquired immunodeficiency diseases; 6) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), patients with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; 7) Use of systemic immunosuppressive drugs within 2 weeks before enrollment, or expected to require systemic immunosuppressive drug treatment during the study, except for the following situations: a) Nasal, inhaled, topical, or local injection (such as intra-articular injection) of corticosteroids; b) Dose does not exceed 10 mg/day of prednisone or other equivalent systemic corticosteroids; c) Prophylactic use of corticosteroids for hypersensitivity reactions; 8) Known or suspected history of allergy to Vidituximab, anti-PD-1 class drugs, or history of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, or patients allergic to excipients of the study drug; 9) History of thrombosis or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.; 10) Patients assessed by the physician as having a high risk of severe bleeding, including but not limited to severe bleeding (bleeding >30 ml within 3 months), hemoptysis (bleeding >5 ml within 4 weeks), if the above conditions occur, gastroscopy/assessment can be performed, and the endoscopic assessment is the standard; or patients with active bleeding or coagulation abnormalities, with a tendency to bleed or currently receiving thrombolytic, anticoagulant, or antiplatelet treatment; 11) Significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction within the past 6 months, severe/unstable angina, or coronary artery bypass surgery, congestive heart failure (New York Heart Association NYHA classification >2), arrhythmias that are poorly controlled or require pacemaker treatment, uncontrolled hypertension with medication (systolic pressure =140 mmHg and/or diastolic pressure =90 mmHg); 12) Other significant clinical and laboratory abnormalities that the researcher believes affect safety evaluation, such as: unco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Recurrence Free Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactChao Yan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed