Gastric Cancer
Conditions
Interventions
Experimental group:S-1 plus oxaliplatin combined with apatinib and camrelizumab as neoadjuvant therapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. The ECOG score is less than or equal to 1 point; 3. ''Adenocarcinoma'' confirmed by pathology and/or cytology; 4. Patients with radical resectable locally advanced gastric cancer or esophageal junction cancer (cT2-3N+M0 or T4/NxM0) who were evaluated for initial treatment of oncology; 5. Peritoneal metastasis was excluded by laparoscopic exploration; 6. Have not received anti-tumor early treatment (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 7. Normal function of major organs or basic requirements for routine clinical trials (no blood transfusion within 14 days prior to screening) : (1) WBC >=4.0x10^9/L; (2) ANC >=1.5x10^9/L; (3) PLT >=100x10^9/L; (4) Hb >=90g/L (5) BIL =50ml/min (Cockcroft-Gault formula); (8) PT, APTT, and INR1.5xULN if assessed by the investigator as suitable for the study, provided sufficient evidence was provided; 8. The heart function was good before enrollment, no myocardial infarction occurred within half a year, hypertension and other coronary heart disease were within the control range; 9. No other uncontrolled benign diseases such as lung, kidney and liver infection before enrollment; 10. Able to understand and comply with the plan. Sign a written informed consent before proceeding with any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 2. Patients who are known to be allergic to the study drug or any excipients thereof, or have experienced severe allergic reactions to other monoclonal antibodies; 3. Patients with a definite tendency to gastrointestinal bleeding within 4 weeks prior to initial medication. Include the following: (1) Locally active ulcerative lesions with positive fecal occult blood; (2) Patients with history of black stool and hematemesis within 28 days; (3) For patients with positive fecal occult blood and no surgical resection of the primary lesion of gastric tumor, and the main researcher of the center thinks that massive gastrointestinal bleeding may occur; 4. Patients with hypertension who cannot be brought to the normal range by antihypertensive drug treatment; 5. Pregnant or lactating female patients or patients who plan to become pregnant during the study treatment period; 6. Patients considered unsuitable for inclusion by researchers; 7. Patients allergic to Apatinib and any component: including but not limited to patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, drug-uncontrolled hypertension within 30 days after major surgery, grade III-IV cardiac insufficiency (NYHA standard), severe hepatic and renal insufficiency (Grade 4); 8. Patients with allergic reactions to the active ingredients and excipients of carrilizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological remission (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete response (pCR) rate;R0 resection rate;objective response rate (ORR);operation-related outcomes;safety; | — |
Countries
China
Contacts
Public ContactCao Dan
West China Hospital, Sichuan University
Outcome results
None listed