Adenocarcinoma of the gastric and gastroesophageal junction
Conditions
Interventions
Single arm:Sintilimab Injection with low-dose chemotherapy and Bevacizumab
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. An unresectable locally advanced, recurrent or metastatic adenocarcinoma of the stomach and gastroesophageal junction confirmed by histopathological examination, and previously treated with first-line standard fluorouracil combined with platinum or taxus; 2. Aged 18 to 75 years old; 3. The ECOG PS score is 0 or 1; 4. From the end of the previous chemotherapy >= 28 days, and recovered from the toxic reaction to for local lesions (non-target lesions) was 4 weeks; 6. According to RECIST v1.1, there is at least one measurable lesion or evaluable lesion; 7. Adequate organ and bone marrow function, as defined below: 1) blood routine examination: absolute neutrophil count >=1.5x10^9/L; Platelet count >=100x10^9/L; Hemoglobin content >=9.0g /dL; 2) liver function: serum total bilirubin (TBIL) =50mL/min; Urinary protein <2+; 4) coagulation function: activated partial thromboplastin time (APTT) and international standardized ratio (INR) <=1.5 ULN; 5) normal thyroid function, defined as thyrotropin (TSH) in the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 in the normal range may also be enrolled; 6) the myocardial enzyme spectrum is in the normal range (if the researchers comprehensively judge that the simple laboratory abnormality with no clinical significance is also allowed to be enrolled); 8. Female subjects of childbearing age or male subjects with female partners of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the treatment period (see section 4.3); 9. Signed the written informed consent and was able to comply with the visit and related procedures stipulated in the program; 10. The estimated survival time is at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Malignancy other than adenocarcinoma of the gastric and gastroesophageal junction (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) diagnosed within 5 years prior to initial administration; 2. Previously received the following therapies: anti-pd-1, anti-pd-l1 or anti-pd-l2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., ctla-4, ox-40, CD137); 3. Receive live attenuated vaccine within 4 weeks prior to enrollment or during the study period; 4. Active, known, or suspected autoimmune diseases; 5. Known history of primary immunodeficiency; 6. Patients with severe hypersensitivity after previous administration of monoclonal antibody. Or allergic to therapeutic drugs or ingredients; 7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 8. Pregnant or nursing female patients; 9. Received systemic systemic treatment (including thymosin, interferon, and interleukin-mediated drugs) with antitumor indications within 2 weeks prior to initial administration; 10. An active autoimmune disease requiring systemic treatment (e.g., the use of disease-relieving drugs, glucocorticoids, or immunosuppressants) occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic; 11. Received systemic glucocorticoid therapy (excluding nasal spray, inhalation or other topical glucocorticoids) or any other form of immunosuppressive therapy 7 days prior to the first administration of the study; Note: physiological dose of glucocorticoids ( 150 mmHg, diastolic blood pressure > 90 mmHg)]. Patients with active bleeding or new thrombotic disease who are taking therapeutic dosage of anticoagulant drugs or who are prone to bleeding; 14. Patients who had received surgical treatment or radiotherapy within 4 weeks before enrollment; 15. There is an underlying medical condition or alcohol/drug abuse or dependence that the investigator considers to be detrimental to the study of drug administration or to the interpretation of drug toxicity or adverse events, or the investigator determines that the patient lacked compliance during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| security;ORR;PFS;DCR;DOR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Quality of life; | — |
Countries
China
Contacts
Public ContactJianwei Yang
Fujian Provincial Cancer Hospital
Outcome results
None listed