gastric cancer
Conditions
Interventions
Experimental group:Combination of Low-Dose Radiotherapy with SOX Regimen and PD-1 Inhibitor
Control group:SOX regimen combined with PD-1 inhibitor
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Gastroscopy and pathologically confirmed gastric cancer (adenocarcinoma/imprinted cell carcinoma); 2. Age 18-70 years old; 3. ECOG score 0-1; 4. Life expectancy >= 3 months; 5. Primary advanced unresectable patients with no previous anti-tumour therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.) 6. Preoperative CT or MRI, PET-CT and other examinations suggest that there is only one unresectable factor confirmed by intraoperative exploration; (1) Patients with N3 lymph node metastasis (N3), mainly patients with group 16 lymph node metastasis (N3 lymphatic metastasis); (2) Extensive or bulky N2 lymph nodes, i.e., at least 1 lymph node =3 cm in diameter or 3 consecutive lymph nodes, each >=1.5 cm in diameter; (3) Localised progression of T4b; (4) Hepatic metastases (H1): <= 5 metastases with a total diameter of <= 8cm; (5) Ovarian metastases (Kukernburg tumour); (7) Physical and organ function permitting major abdominal surgery 8. adequate organ and bone marrow function; 9. not have an active, known or suspected autoimmune disease 10. not be involved in other clinical studies 11. agree to provide blood and histological specimens; 12. no serious medical contraindications affecting anaesthesia and surgery; 13. have no haematological disorders affecting postoperative haemoglobin levels; 14. Understand the trial process and be able to comply with the trial protocol for the duration of the trial, including co-operation with any treatments, investigations, tests, follow-up visits and questionnaires required to complete the trial;
Exclusion criteria
Exclusion criteria: 1. Exclude patients with a positive HER2 test; 2. exclude patients with endoscopy showing signs of active bleeding from the lesion; 3. Exclude patients with moderate/large amounts of ascites; 4. Exclude distal metastases other than oligometastases as defined in the inclusion criteria, such as lung, brain, bone and peritoneum; 5. Excluding patients with urine protein >=2+ and 24-hour urine protein quantification >1.0g. 6. Near cardia and pylorus obstruction affecting the patient's feeding and gastric emptying, or impaired swallowing of tablets; 7. Those who have been treated with other medications before enrolment or those who cannot be guaranteed to follow the requirements of the study after enrolment; 8. allergy to the drugs in this protocol; 9. patients with a combination of other tumours 10. patients who are pregnant or breastfeeding, or expect to plan a pregnancy during study treatment. 11. have received systemic systemic therapy with herbs with anti-tumour indications or drugs with immunomodulatory effects (including thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose of study drug. 12. use of immunosuppressive drugs, excluding topical glucocorticoids by nasal, inhalational or other routes or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/day of prednisone or equivalent dose of other glucocorticosteroids), or use of hormones for the prevention of contrast allergy, within 4 weeks prior to the first dose of study treatment; 13. any medical history or extant clinical evidence of conditions that may confound the results of the study, interfere with the patient's compliance with the trial protocol throughout the duration of study treatment, or are not in the patient's best interest; 14. Serious uncontrolled medical conditions or general conditions that, in the judgement of the investigator, make the subject unsuitable for enrolment in the study, including, but not limited to: active viral infections such as Human Immunodeficiency Virus, Hepatitis B, Hepatitis C, etc.; severe cardiovascular disease, uncontrolled ventricular dysrhythmias, myocardial infarction in the last 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric disorders that would interfere with the patient's ability to sign informed consent; Medically uncontrolled hypertension; Immunodeficiencies (other than splenectomy) or other conditions that, in the opinion of the investigator, expose the patient to a high risk of toxicity; and Organ transplants requiring immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Major pathological response rate;Objective Response Rate;Disease Control Rate;Progression-Free Survival ;Disease-Free Survival;Overall Survival ; | — |
Countries
China
Contacts
Public ContactHanhui Yao
Anhui Provincial Cancer Hospital
Outcome results
None listed