Gastric cancer
Conditions
Interventions
NA:NA
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subjects has to voluntarily join the study and sign the informed consent form for the study. 2) =18 years, male or female. 3) The histologic diagnosis of the gastric adenocarcinoma or gastroesophageal junction adenocarcinomas (Siewert III). 4) T3-4N1-3M0 stage (according to AJCC, 8th). Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with . 5) No prior anti-tumor treatment is allowed(including chemotherapy, radiotherapy, targeted therapy or immune therapy). 7) Patients with a life expectancy of at least 3 months. 8) ECOG 0-2. 9) Baseline tissue had been completed 1021 genetic testing. Baseline blood had been completed circulating tumor DNA test with positive status.
Exclusion criteria
Exclusion criteria: 1) Cancer other than gastric adenocarcinoma or gastroesophageal junction cancer (Siewert III). 2) Active or documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis). 3) Inability to swallow, malabsorption syndromes, or uncontrolled nausea, vomiting, diarrhoea or other gastrointestinal disorders that seriously affect the administration and absorption of medicines; 4) History of other carcinomas or presence of pathogenic cancer within past five years (excluding cured basal cell carcinoma or cervical epithelial cancer). 5) Active autoimmune disease undergoing treatment with systemic agents within 2 years prior to the initiation of study treatment, or autoimmune disease that, in the judgment of the investigator, has a potential for relapse or planned treatment. 6) Grade =2 peripheral nerve disease was defined according to NCI CTCAE v5.0. 7)The presence of known interstitial lung disease or noninfectious pneumonia that is currently symptomatic or previously required systemic glucocorticoid therapy may affect the evaluation or management of toxicity related to the study treatment, as determined by the investigator. ; Note: Physiologic doses of glucocorticoids (=10 mg per day of prednisone or equivalent) were allowed. 8)Active pulmonary tuberculosis is known to be present. Suspected of active tuberculosis of the subjects, need to check the chest X-ray and sputum and excluded by a clinical symptoms and signs; 9) Anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to the initiation of study treatment. 10) Prior allogeneic stem cell or solid organ transplantation. 11) Female patients who are in pregnancy or lactation and refuse contraception. 12) Any comorbidity or complication that could potentially interfere with with anti-tumor therapy or surgical treatment. 13) The patient has been enrolled in other clinical trials (excluding observational, non-interventional clinical study or a follow-up period for an interventional study). 14) Recent history (within 4 weeks) of hemoptysis. 15) Any condition considered by the investigator to be potentially risky to receive the study drug, or that would interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results. 16) Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationship between ctDNA and the efficacy of preoperative therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between postoperative ctDNA-based MRD status and disease-free survival; | — |
Countries
CHINA
Contacts
Public ContactLv jing
The Affiliated Hospital of Qingdao University
Outcome results
None listed