gastric adenocarcinoma
Conditions
Interventions
observation group:AK104 (cardonilizumab), 10mg/kg intravenously, day 1, every 3 weeks, Q3W
Oxaliplatin: 130 mg/m^2, IV, day 1, Q3W
Capecitabine: 1000mg/m^2 orally, twice daily, day 1 to day 14, Q3W.
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~75 years old; 2. Histologically confirmed, untreated gastric or gastroesophageal junction (GEJ) adenocarcinoma. Only Siewert type III and Siewert type II subjects who do not require combined thorotomy are admitted for GEJ cancer. 3. CT, MRI, or PET-CT prior to treatment identified a single unresectable factor: No. 16a2/b1 lymph node metastasis; 4. Before treatment, laparoscopic exploration shows no intraperitoneal metastasis (CY1/P1); 5. Have not received prior treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. ECOG PS: 0-1; 7. Anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, lentinus mushroom polysaccharide, interleukin-12, etc.) used in the past must be = 2 weeks from the beginning of the study; 8. Hepatitis B surface antigen (HBsAg) (-) and Hepatitis B Core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be <1000 copies /mL or <200 IU/mL or < upper limit of normal in the Study Center (ULN) for inclusion, HCV antibody (-); 9. Normal function of major organs; 10. Before enrollment, the heart function was good, no myocardial infarction occurred within half a year, hypertension and other coronary heart disease were under control; 11. No other uncontrollable benign diseases such as lung, kidney and liver infection were present before enrollment; 12. Female patients must meet the following requirements: postmenopausal, surgically sterilized, or fertile patients must meet the following requirements: 1) Serum pregnancy test results within 7 days prior to enrollment must be negative; 2) Agree to adopt annual failure rate <1% of contraception or abstinence; 3) Do not breastfeed. Male patients must meet: consent to abstinence or use contraception. 13. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with other active malignant tumors within 5 years or at the same time. 2. Patients with known HER2-positive gastric/GEJ adenocarcinoma. 3. Distant metastases other than No. 16a2/b1 confirmed by imaging or pathological examination, including but not limited to liver metastases, peritoneal metastases, lung metastases, bone metastases, adrenal metastases, central nervous system metastases, pia meningeal metastases, spinal cord compression or pia meningeal diseases. 4. Patients who are preparing for or have previously received an organ or bone marrow transplant. 5. History of myocardial infarction and poorly controlled arrhythmia (QTc interval = 450 ms for men and 470 ms for women) in the 6 months prior to enrollment (QTc interval was calculated using Fridericia formula). 6. Presence of NYHA standard ? ~ ? cardiac insufficiency or heart color ultrasound: LVEF (left ventricular ejection fraction) 10 mg/day prednisone) or other immunosuppressive drugs. 13. Any active infection that required systematic anti-infective therapy during the first 14 days of enrollment; The exception is prophylactic antibiotic treatment (such as prevention of urinary tract infections or chronic obstructive pulmonary disease). 14. Previously received other antibody/drug therapy targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc. 15. Receiving treatment in another clinical study or plan to start treatment in this study less than 14 days after the end of treatment in the previous clinical study. 16. Known history of severe allergy to any monoclonal antibody or investigational drug excipients. 17. Known history of psychotropic substance abuse or drug use; Patients who have stopped drinking alcohol can be enrolled. 18. Patients who have a risk of increased participation in research and investigational medication, or other severe, acute, or chronic medical conditions that the investigator determines are not suitable for clinical study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of R0 resection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological primary remission rate;Drug safety;Surgical safety; | — |
Countries
China
Contacts
Public ContactXiaodong Chen
Sichuan Cancer Hospital
Outcome results
None listed