Gastric cancer
Conditions
Interventions
experimental group: Sindilimumab combined with conventional chemotherapy
Sponsors
Quanzhou First Hospital Affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable or unresectable locally advanced, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma and hepatoid adenocarcinoma) confirmed by histopathological examination. 2. Patients aged >= 18 years and 6 months. 5. Patients who received palliative treatment for local lesions (non target lesions) for more than 2 weeks after the first treatment. 6. According to RECIST v1.1, patients with at least one measurable or evaluable lesion. 7. Patients with sufficient organ and bone marrow function are defined as follows: Blood routine: absolute neutrophil count >= 1.5 x 10^9 / L; platelet count >= 100 x 10^9 / L; hemoglobin content >= 9.0 g / dl. Liver function: serum total bilirubin (TBIL) = 50ml / min; urine protein = 12 weeks. 9. Female subjects of childbearing age or male subjects with female sexual partners of childbearing age should take effective contraceptive measures during the whole treatment period and six months after the treatment period (see Section 4.3). 10. Patients who have signed the written informed consent and can comply with the visit and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with known endoscopic signs of active bleeding. 2. The obstruction of cardia and pylorus affects the patient's eating and gastric emptying, or swallowing tablets. 3. Patients with gastric and gastroesophageal junction adenocarcinoma diagnosed as HER2 positive. Previous systematic treatment for advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction. 4. Patients diagnosed with malignant diseases other than gastric cancer within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and / or cancer in situ after radical resection); 5. Patients who are currently participating in the intervention clinical research treatment, or received other research drugs or used research instruments within 4 weeks before the first administration; 6. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 7. Patients who have received systemic treatment of Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 8. Active autoimmune diseases occurred in patients requiring systemic treatment (e.g. using disease relief drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy; 9. Study patients who are receiving systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: physiological dose of Glucocorticoid (<=10 mg / day of prednisone or equivalent) is allowed; 10. Patients with known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Patients who are known to be allergic to any monoclonal antibody or component of chemotherapy drug preparation (with grade 3 or above allergic reaction); 12. Not fully recovered from the toxicity and / or complications caused by any intervention (i.e. <= grade 1 or reaching baseline, excluding fatigue or hair loss) before the start of treatment; 13. Patients with known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive); 14. Patients with active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number higher than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the study (1) The HBV viral load was less than 1000 copies / ml (200 IU / ml) before the first administration, and the subjects should receive anti HBV treatment during the whole study chemotherapy to avoid virus reactivation; (2) For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not required, but close monitoring of virus reactivation is needed. 15. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the detection limit); 16. Patients who received live vaccine within 30 days before the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and serious adverse events;OS;PFS; | — |
Countries
China
Contacts
Public ContactYan Huang
Quanzhou First Hospital Affiliated to Fujian Medical University
Outcome results
None listed