gastric cancer
Conditions
Interventions
single arm:The combination is based on the second-line treatment regimen recommended by the guidelines Apatinib: 250mg orally, QD
Carilizumab: 200mg/ time, intravenous infusion, d1, Q3W
Efficacy and adverse reactions were evaluated every 3 cycles.
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18-75 years; 2. Patients with advanced gastric cancer who failed first-line therapy; 3. Expected survival >= 3 months; 4. There should be at least one measurable lesion (RECIST1.1 criteria) with spiral CT or MR target lesion >= 10mm and lymph node >= 15mm; 5. ECOG 1 or less; 6. The function of vital organs meets the following requirements (no use of blood components or cell growth factors is recommended for the first 2 weeks of study treatment) : A. Total bilirubin TBil = 45ml/min; E. Hb >= 90g/L; F. The absolute count of neutrophils ANC >= 1.5 x 10^9/L; G. Platelet count PLT >= 80 x 10^9/L; H. Albumin Alb >= 29g/L; I. No anticoagulant treatment is received;The coagulation parameters of anticoagulants should be within the expected range; J. The international standardized value of coagulation function INR <= 1.5 x ULN; K. APTT of activated partial thromboplastin <= 1.5 x ULN; 7. Routine and normal urine and stool; 8. The subject's wound has completely healed after surgery, and there is no bleeding tendency; 9. Negative pregnancy test for women of childbearing age;Women of child-bearing age are willing to use high-efficiency methods of contraception during the trial and for 60 days after the last dosing;Male subjects whose partners are women of child-bearing age should be surgically sterilized or agree to use a high-efficiency method of contraception during the trial and for 120 days after the last administration of the test drug; 10. Voluntary participation; Good compliance, willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. People with hypertension, the antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg), suffering from II or higher level of coronary heart disease, arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac insufficiency; 2. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, etc.); 3. Abnormal coagulation function and bleeding tendency; 4. Subjects who are preparing for or have previously received tissue/organ transplants; 5. The tumor ruptures or invades adjacent organs; 6. Subjects with any active, known or suspected autoimmune disease; 7. Treatment with corticosteroids (> 10mg/ day of bonisone or equivalent) or other immunosuppressive agents.In the absence of active immune disease, inhaled or topical use of steroids and a therapeutic dose of > 10mg/ day of epinephrine replacement were allowed; 8. Subjects who received treatment with anti-tumor vaccine or other immune-stimulating anti-tumor drugs (interferon, interleukin, thymopeptide, immunocell therapy, etc.) within 1 month before the first medication;Subjects who received or will receive live vaccine within 30 days before the first dose; 9. Patients who underwent major surgery within 4 weeks prior to the first medication were excluded; 10. Uncontrolled or symptomatic active central nervous system (CNS) metastases known to present with clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pneumomeningeal disease, and/or progressive growth.Patients with a history of central nervous system metastases or spinal cord compression who were clearly treated and showed stable clinical performance 4 weeks after discontinuation of anticonvulsants and steroids prior to initial administration were eligible to be enrolled. 11. 6 months before entering the study, the following condition: serious/unstable angina, myocardial ischemia and myocardial infarction with II class above, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher) of the subjects.Ruled out according to the NYHA standard III ~ IV level cardiac insufficiency or heart colour to exceed examination: LVEF, left ventricular ejection fraction = 2000 IU/mL;Hepatitis C: Hepatitis C virus antibody (HCV Ab) positive, HCV RNA positive, and abnormal liver function;Co-infection with hepatitis B and hepatitis C; 15. Subjects who had a severe infection within 4 weeks prior to the first treatment were excluded, including but not limited to complications of infection requiring hospitalization, bacteremia, severe pneumonia, etc.Excluded subjects with any active infection; 16. A known history of positive human immunodeficiency virus (HIV) tests or a known history of acquired immunodeficiency syndrome (AIDS); 17. Exclude subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 18. Severe allergic reactions to other monoclonal antibodies; 19. Allergic or intolerant to infusion; 20. Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactMudan Yang
Shanxi Cancer Hospital
Outcome results
None listed