Gastriccancer
Conditions
Interventions
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed locally advanced or metastatic gastric adenocarcinoma who are not suitable for surgical treatment, with negative Her2 test (immunohistochemistry - or +, or immunohistochemistry++, FISH -); 2. Aged 18 to 75 years old, regardless of gender; 3. Expected survival time >= 12 weeks; 4. According to the Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1), there is at least 1 measurable or evaluable lesion; 5. According to the Eastern Cooperative Oncology Group physical status score (ECOG PS score) is 0-2 points; 6. Patients receive sintilimab combined with chemotherapy or targeted drugs (chemotherapy regimens include XELOX, SOX, oxaliplatin + 5FU, cisplatin + 5FU, paclitaxel, or apatinib, etc.); 7. Having adequate organ and bone marrow function, as defined below: (1) Blood routine: absolute neutrophil count >=1.5x10^9/L; platelet count >=100x10^9/L; hemoglobin content >=9.0 g/dL; (2) Liver function: serum total bilirubin (TBIL) = 50 mL/min; urine dipstick test results show urine protein <2+; (4) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5xULN.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods; 2. Received systemic therapy for advanced or metastatic gastric cancer in the past; 3. Previous therapy with anti-PD-1, anti-PD-L1, or another drug that stimulates or synergistically inhibits T-cell receptors (eg, CTLA-4, OX-40, CD137). 4. Patients with a high risk of bleeding or perforation due to the obvious invasion of the aorta or trachea by the tumor, or patients with fistula formation; 5. Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other pulmonary diseases; 6. Receive live attenuated vaccines within 4 weeks before enrollment or plan to receive live attenuated vaccines during the study; 7. Active, known or suspected autoimmune disease; 8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. Untreated acute or chronic active hepatitis B or C infection. For patients receiving antiviral therapy, under the condition of monitoring the number of virus copies, the doctor will judge whether they are eligible for inclusion according to the individual situation of the patient; 10. Uncontrolled concurrent diseases include but are not limited to: HIV-infected persons (HIV antibody positive). Serious infections that are active or poorly controlled clinically. Presence of severe or uncontrolled systemic disease (eg, severe psychiatric, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension Evidence of greater than or equal to CTCAE Grade 2 hypertension after treatment]). Those with active bleeding or new thrombotic disease who are taking therapeutic anticoagulant drugs or who have a tendency to bleed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Progress free survival (PFS);Overall survival (OS);Adverse effect (AE); | — |
Countries
China
Contacts
Public ContactWang Chaojie
Henan Provincial People's Hospital
Outcome results
None listed