Gastric cancer
Conditions
Interventions
experimental group:Phase I: Gastrojejunostomy with vagotomy is performed, followed by 3-4 cycles of conversion therapy. Subsequently, tumor response is assessed to guide the implementation of Phase II
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in this study must meet all of the following criteria: 1. sign written informed consent prior to performing any trial-related processes; 2. 18 to 75 years of age; 3. gastric cancer with TNM stage cT1-4/N0-3/M0-1 evaluated as not feasible for R0 resection and histopathologically confirmed adenocarcinoma; 4. Combined pyloric obstruction; 5. HER-2 negative. 6. agree to provide subjects with formalin-fixed tumour tissue specimens or fresh biopsy tumour lesion tissues for marker testing; 7. ECOG score of 0-1; 8. expected survival time >= 6 months; 9. Adequate organ function without serious abnormalities of haematopoietic function and abnormalities of cardiac, pulmonary, hepatic and renal function as well as immunodeficiency, subjects need to satisfy the following laboratory indexes: (1) Haemoglobin (HGB) >= 90g/L; (2) Neutrophil (NEUT) >= 1.5 x 10^9/L or white blood cell count (WBC) >= 3 x 10^9/L; (3) Platelets (PLT) >= 90 x 10^9/L; (4) Mentholated aminotransferase (AST) <= 2.5 x ULN; (5) Alanine aminotransferase (ALT) <= 2.5 x ULN; (6) Total bilirubin (TBIL) <= 1.5 x ULN; (7) Blood creatinine (SCr) <= 1.0 x ULN.
Exclusion criteria
Exclusion criteria: Subjects meeting the following criteria were not eligible for enrolment in this study: 1. a diagnosis of a malignancy other than gastric cancer within 5 years prior to the combined first dose; 2. currently being treated in an interventional clinical study or have received other investigational drugs or have been treated with investigational devices within 4 weeks prior to the first dose; 3. Previously received radiotherapy, systemic chemotherapy, tumour-targeted therapy, or immunotherapy for gastric cancer; 4. symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical signs of spinal cord compression; 5. ongoing systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days prior to the study intervention; Note: physiological doses of glucocorticoids (=++ and confirmed 24-hour urine protein quantification >1.0 g; (8) Patients with mental disorders and unable to co-operate with treatment; 11. History or evidence of disease that may interfere with the results of the test, prevent the subject from participating in the study throughout the study, abnormal values of treatment or laboratory tests, or other conditions that the investigator believes are unsuitable for enrolment The investigator believes that there are other potential risks unsuitable for participation in the study; 12. the presence of conditions that may increase the risk of participation in the study and study medication, or other severe, acute and chronic conditions that, in the judgement of the investigator, make participation in the clinical study unsuitable 13. known propensity for gastrointestinal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Postoperative Complications;Pathologic complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression-Free Survival;R0 resection rate; | — |
Countries
China
Contacts
Public ContactHanhui Yao
Anhui Cancer Hospital
Outcome results
None listed