HER2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
single arm:Capecitabine/Oxaliplatin (XELOX Regimen) in Combination with Regorafenib and PD-1 Monoclonal Antibody
Sponsors
Shanghai Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with age >= 18 years <= 75 years, regardless of gender; 2. Patients (including signet ring cell carcinoma of the stomach) with unresectable locally advanced or metastatic HER2 negative adenocarcinoma of the stomach or gastroesophageal junction confirmed by histology and / or cytology; 3. For patients who have not received the standard chemotherapy plan for advanced tumor before, the adjuvant or neoadjuvant chemotherapy must be stopped for at least 6 months and there is no recurrence or disease progression within 6 months; 4. Patients with at least one measurable tumor focus (according to RECIST One point one Definition, note: previously treated lesions cannot be regarded as measurable target lesions, unless there is definite progression after radiotherapy; 5.ECOG Patients with physical strength score of 0-1; 6. Patients who have an estimated survival time of more than 3 months; 7. Patients with sufficient organ function; 8. Patients who can provide archived tumor tissue samples or can receive fresh tumor tissue biopsy; 9. The fertile eligible patients (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 5 months after the last medication; the blood or urine pregnancy test of female patients in the childbearing age must be negative within 7 days before the first use of the study drug. 10. The subjects should have informed consent to the study before the trial, and sign a written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1.With history of any other malignancy within the past 5 years (except carcinoma in situ or basal cell carcinoma or squamous cell carcinoma of the skin); 2.Received other non-marketed investigational drugs or treatments within 4 weeks prior to the first dose of the study drug. 3.Received any major visceral surgical procedure (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of study drug. 4.Received treatment with systemic corticosteroids within 14 days prior to the first dose of study drug. 5.Received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to the first dose of study drug. 6.Received live attenuated vaccines 4 weeks prior to the first dose of study drug. 7.Previous received allogeneic hematopoietic stem cell transplantation or organ transplantation. 8.The adverse reactions of previous anti-tumor treatment have not been recovered to CTCAE 5.0 grade 2. 10.Patients with central nervous system metastasis or meningeal metastasis. 11.Inability to orally swallow drugs or other gastrointestinal diseases that affect the absorption of oral drugs (such as complete intestinal obstruction, etc.). 12.Patients with active infection before the first dose of the study drug and currently requiring systemic anti-infective treatment. 13.With history of immunodeficiency, including a positive HIV antibody test. 14.Active hepatitis B (hepatitis B virus > 1000 copies/ml or 200 IU/ml), prophylactic antiviral therapy other than interferon is allowed; hepatitis C virus infection. 15.Patients with current interstitial lung disease. 16.With history of serious cardiovascular and cerebrovascular diseases, including but not limited to: Patients with severe cardiac rhythm or conduction abnormalities, such as arrhythmia requiring clinical intervention, grade II-III atrioventricular block; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months prior to the first dose of drug; New York Heart Association (NYHA) functional class >= II or ejection fraction (LVEF) = Grade 2 bleeding or factors that, in the judgment of the investigator, pose a high risk of bleeding (eg, active peptic ulcer or esophageal varices or tumour invading major blood vessels). 19.Gastrointestinal perforation, abdominal fistula, or intra-abdominal abscess within 6 months prior to the first dose of study drug; or current high-risk factors for hollow organ perforation/fistula formation judged by the investigator (eg, tumor infiltration into the outer layer of the hollow organ wall). 20.Clinically uncontrolled third space fluid, judged by the investigator to be unsuitable. 21.Known hypersensitivity to fluoropyrimidines or platinum compounds or monoclonal antibodies. 22.Known alcohol or drug dependence. 23.Patients wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;DCR;PFS;OS; | — |
Countries
China
Contacts
Public ContactJin Lin
Shanghai Oriental Hospital
Outcome results
None listed