Gastric Cancer
Conditions
Interventions
A: chemotherapy combined with anti-pd1 immunotherapy
B:Active supportive therapy
Sponsors
The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Non-resectable locally advanced, recurrent or metastatic adenocarcinomas of the stomach and gastroesophageal junction confirmed by histopathological examination (including sig-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma); 2. Aged 18 to 75 years old; 3. Progress after treatment with >=2 lines of chemotherapy; 4. According to RECIST v1.1, there is at least one measurable lesion or evaluable lesion; 5. Adequate organ and bone marrow function, as defined below: 1) blood routine examination: absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) 100x10^9/L or higher;Hemoglobin content (HGB) >=9.0g/dL; 2) liver function: patients without liver metastasis required serum total bilirubin (TBIL) =50 mL/min (calculated by Cockcroft/Gault formula): For women: Ccr= (140- age) x weight (kg) x 0.85; 72 x serum creatinine (mg/dL); For men: Ccr= (140- age) x weight (kg) x 1.00; 72 x serum creatinine (mg/dL); 6. Expected survival >=12 weeks; 7. Female subjects of childbearing age or male subjects with female partners of childbearing age should be treated throughout the treatment period and 6 months after the treatment period to take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Known deficiency of DPD enzyme (or above grade 3 mucosal toxicity after previous treatment with fluorouracil); 2. Known signs of active focal bleeding were shown under endoscopy; 3. Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can be set); 4. Known history of primary immunodeficiency; 5. Active tuberculosis is known; 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 7. Known a history of human immunodeficiency virus (HIV) infection (i.e. HIV antibody positive); 8. Severe infection in the active stage or poorly controlled clinically; 9. Severe cardiac, renal and other organ dysfunction; 10. Pregnant or nursing female patients; 11. Other acute or chronic conditions, psychiatric disorders, or laboratory test abnormalities that may result in increased risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and in the judgment of the investigator disqualify the patient from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;Safety; | — |
Countries
China
Contacts
Public ContactHe Yulong
The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Outcome results
None listed