Gastric and gastroesophageal junction adenocarcinoma
Conditions
Interventions
Treatment group:Sintilimab: 200 mg IV on day 1 every 3 weeks
Anlotinib: 12 mg daily for 2 weeks, then 1 week off, repeated every 3 weeks
Sponsors
Zhejiang University Second Affiliated Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) confirmed by histopathological examination; 2. Body weight >=40kg; Or BMI > 18.5; 3. Age >=18 years old and =1.5×10^9/L; Platelet count >=100×10^9/L; The hemoglobin level was >=9.0 g/dL. (2) Liver function: total bilirubin (TBIL) =50mL/min; The results of urine dipstick test showed that urine protein was less than 2+. (4) Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) =12 weeks; 10.Female participants of childbearing age or male participants with a female partner of childbearing age were required to use an effective contraceptive method for the entire treatment period and for 6 months after the treatment period (see Section 4.3); 11. Provide written informed consent and comply with protocol-specified visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Known signs of active bleeding under endoscopy; 2. Obstruction of the cardia and pylorus may affect the patient's eating and gastric emptying, or may cause difficulty in swallowing tablets; 3. Prior treatment with a VEGF or VEGFR inhibitor; 4. Malignant diseases other than gastric cancer diagnosed within 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma); 5. Symptomatic or high-risk obstruction, bleeding, perforation, pneumonia (including patients with non-communicable pneumonia who had received hormone therapy in the past and patients with pneumonia who were receiving treatment); 6. Are currently participating in an interventional clinical study treatment, or have received another study drug or study device within 4 weeks before the first dose; 7. Received anti-tumor indications of Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except drugs used locally to control pleural effusion or ascites) systemic treatment within 2 weeks before the first dose; 8. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy; 9. Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy (>10mg/ day of prednisone or equivalent) within 7 days before the first study dose 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Known allergy to any monoclonal antibody or chemotherapy drug (capecitabine, cisplatin) ingredients (grade 3 or above anaphylaxis). 12. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade <=1 or baseline, excluding fatigue or alopecia); 13. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center); Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: a) HBV viral load <1000 copies /ml (200IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment to avoid viral reactivation b) Subjects with anti-HBc (+), HBsAg (-), anti-hbs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required 15. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 16. Received a live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed. 17. Pregnant or lactating women; 18. The presence of any serious or uncontrolled systemic illness, such as: a) significant rhythm, conduction or morphological abnormalities on resting ECG that are symptomatic and diffic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Duration of remission, DoR;Progression free survival, PFS;Safety;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactQinghua Yao
Zhejiang University Second Affiliated Hospital of Traditional Chinese Medicine
Outcome results
None listed