Gastric/Gastro-esophageal junction adenocarcinoma
Conditions
Interventions
Single arm:The treatment period of the study was intraperitoneal hyperthermic perfusion chemotherapy combined with PD-L1 monoclonal antibody/fruquintinib and systemic treatment with the AS regimen. Th
S-1: D1-D14, Q21d)
PD-L1 monoclonal antibody is administered once every three weeks. Fruquintinib 3mg qd D1-14, Q21 days.
3. During the treatment process, imaging reexaminations should be conducted every three months to
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in the study, signed the consent form, had good compliance, and obeyed the follow-up. They were willing and able to abide by the protocol during the study period. 2. 18 years old = 70 years old; 3. ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) score 0-1; 4. The primary lesion of the stomach was diagnosed as adenocarcinoma of the stomach or the esophagogastric junction by gastroscopy biopsy histopathology (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por). 5. The tumor lesion is located in the stomach or the esophagogastric junction (Siewert type II/III), and HER-2 is negative; 6. The clinical stage is cTxNxM1*, P1 (specifically referring to "P1: peritoneal Metastasis in the 14th Edition of the Japanese Gastric Cancer Protocol", and there is no distant metastasis other than peritoneal metastasis), with or without ascites; 7. Good bone marrow reserve function: HB>=90g/L; ANC >=1.5×10^9/L; PLT >=100×10^9/L; 8. Good liver and kidney function reserves: TBIL and DBIL <= 1.5 times the upper limit of the normal value (ULN); ALT and AST <= 2.5×ULN; Crea<=1×ULN; 9. Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN, activated partial thromboplastin time (APTT) <=1.5 times ULN; 10. The patient's blood pressure is well controlled. Up to two antihypertensive drugs are applied, and the blood pressure is kept below 140/90 MMHG. 11. No chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. have been administered; 12. Fertile women must have a negative urine or serum pregnancy test result within 7 days before enrollment and must agree to take effective contraceptive measures during the study period and for 6 months after the study ends. Unsterilized men must agree to take effective contraceptive measures during the study period and within six months after the end of the study, and agree to avoid sperm donation during the same period. 13. Have the ability to act independently, the ability to swallow tablets, and no gastrointestinal diseases that affect the absorption of oral drugs; 14. Agree to provide hematological and histological samples.
Exclusion criteria
Exclusion criteria: 1. There are distant metastases other than peritoneal metastases. 2. Complications of gastric cancer requiring emergency treatment, such as bleeding, perforation and obstruction. 3. Suffer from other malignant tumors within five years. 4. Body temperature >= 38? or complicated with infectious diseases requiring systemic treatment. 5. For those with a history of uncontrolled epilepsy, central nervous system disease, or mental disorder, the investigator will determine whether the clinical severity hinders the signing of informed consent or affects the patient's compliance with oral medications. 6. Clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention, or recent history of myocardial infarction within 12 months 7. Severe respiratory diseases. 8. Severe liver and kidney dysfunction. 9. Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome, which may affect the absorption of oral drugs. 10. Have a history of venous thrombosis. 11. Patients with active autoimmune diseases or those with a history of autoimmune diseases that may relapse (Remarks: Patients with the following diseases will not be excluded and can proceed to further screening): (1). Controlled type 1 diabetes mellitus. (2). Hyperthyroidism or hypothyroidism (if it can be controlled with only hormone replacement therapy). (3). Controlled celiac disease. (4). Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia). (5). Any other diseases that are not expected to relapse without external triggering factors. 12. Have a history of the following diseases: interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases including diabetes mellitus, hypertension, pulmonary fibrosis, acute lung diseases, etc. 13. Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection, etc. 14. Have a known history of HIV infection. 15. Patients with untreated chronic hepatitis B or chronic HBV carriers. Those with hepatitis B virus (HBV) DNA exceeding the upper limit of normal (ULN) or patients with positive hepatitis C virus (HCV) RNA should be excluded. 16. Patients who have received continuous glucocorticoid treatment (excluding local application) within 1 month or those who require immunosuppressive treatment due to organ transplantation. 17. Pregnant or lactating women. 18. Patients who have participated in or are currently participating in other clinical studies (within the past 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of 6-month Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of 1-year Overall Survival; | — |
Countries
China
Contacts
Public ContactYuehong Cui
Zhongshan Hospital Fudan University
Outcome results
None listed