gastric cance
Conditions
Interventions
The study targets patients with histologically/cytologically confirmed gastric (or gastroesophageal junction) adenocarcinoma, diagnosed with gastric cancer peritoneal metastasis through laparoscopic e
Cadonilimab 10mg/kg, administered by intravenous infusion on day 1 of each cycle
S-1 oral administration after patients meal (generally within 48 hours after surgery), 80-120 mg (<1.25 m2, 40 mg
1.25 to =1.5 m2, 50 mg
and = 1.5 m2, 60 mg), divided into two doses, oral administration for 14 days
one cycle every 3 weeks, treatment lasts for one cycle.
Cadonilimab 10mg/kg, administered by intravenous infusion on day 1 of each cycle
oxaliplatin administered on day 1 of the first cycle at a dose of 130 mg/m2 by intravenous infusion
oral administration of tegafur 80-120mg twice daily from day 1 to day 14
one cycle every 3 weeks, treatment lasts for 4 cycles.
During the conversion therapy phase, imaging examinations will be conducted every 6 weeks (±7 days). After completing 4 cycles of treatment, a m
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to enter this study: 1) Voluntarily sign a written informed consent form. 2) Age =18 and =75 years, both males and females are eligible. 3) ECOG performance status of 0 or 1. 4) Histologically/cytologically confirmed advanced gastric (or gastroesophageal junction) adenocarcinoma. 5) Presence of peritoneal metastasis from gastric cancer confirmed by laparoscopic exploration and photography (CT or MRI confirms no metastasis outside the peritoneum), with PCI = 20. 6) No prior anticancer therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) for gastric or gastroesophageal junction. 7) Expected survival period >3 months. 8) At least one measurable lesion according to RECIST v1.1. 9) Good organ function determined by the following requirements: a. Hematology (subjects are not allowed to receive blood transfusions or growth factor support therapy within 7 days before the first dose): i. Absolute neutrophil count (ANC) =1.5×109/L (1500/mm3); ii. Platelet count =100×109/L (100000/mm3); iii. Hemoglobin =90 g/L. b. Renal function: i. Calculated creatinine clearance rate (CrCl) = 50 mL/min or serum creatinine =1.5×ULN CrCL (mL/min) = {(140-age)×weight (kg)×F}/(SCr(mg/dL)×72) F: 0.85 (for females) or 1 (for males) c. Liver function: i. Total bilirubin (TBIL) =1.5×ULN; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN (=5×ULN if liver metastasis is present). iii.Serum albumin (ALB) =28 g/L. d. Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) =1.5×ULN (unless the subject is receiving anticoagulant therapy and INR and APTT are within the expected range of anticoagulant therapy). e. Cardiac function: Left ventricular ejection fraction (LVEF) = 50%. 10) no other serious medical conditions that conflict with this protocol (such as autoimmune diseases, immune deficiencies, organ transplants, or other conditions requiring continuous hormone therapy); 11) Fertile female subjects must undergo a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test results cannot be confirmed as negative, a serum pregnancy test is required, based on the serum pregnancy result), and the result is negative. If a fertile female subject has sex with an unsterilized male partner, the subject must use a highly effective method of contraception since screening and must consent to use an effective method of contraception during the study treatment period and for 180 days after the end of the study treatment period. Whether to stop contraception after this time point should be discussed with the investigator. 12) If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening until the 80th day after the last dose; Whether to stop contraception after this time point should be discussed with the investigator. 13) The subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study
Exclusion criteria
Exclusion criteria: tients with any of the following were not admitted to the study: 1) Patients have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery, or immunotherapy). 2) Known HER-2 positive patients. 3) Patients with distant metastases other than abdominal metastasis confirmed by imaging (including liver metastasis, para-aortic lymph node metastasis, lung metastasis, etc.); 4) Previous history of gastric surgery; 5) There are many factors affecting the absorption of oral drugs such as inability to swallow, chronic diarrhea and intestinal obstruction; 6) Within 3 months before signing the informed consent, there have been clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic ulcer or vasculitis; At baseline, gastroscopy is required, and if the gastroscopy results indicate severe gastric ulcer or the researchers judge that there is a risk of bleeding, they cannot be enrolled in the group (except those who receive gastroscopy within 3 months before signing the informed consent to rule out such conditions and have negative occipal blood at baseline); Gastrointestinal perforation or fistula within 6 months prior to signing the informed consent; 7) Subjects with previous malignancies, unless complete elimination has been achieved at least 5 years prior to study entry, and additional treatment is not or is not expected to be required during the study period (exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast); 8) Subjects with a known or suspected active autoimmune disease. Allow inclusion of subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers; 9) History of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (grade 2 or higher as defined by the New York Heart Association Functional Scale), or vascular disease (such as aortic aneurysms at risk of rupture), or other heart damage (such as poorly controlled arrhythmias, myocardial ischemia) that may affect the safety evaluation of the study drug in the 12 months prior to initial administration. 10) Any arterial thromboembolism event, NCI CTCAE 5.0 grade 3 or above venous thromboembolism event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months prior to initial administration; Acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before first administration; Current hypertension with systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg after oral antihypertensive medication. 11) Subjects with conditions requiring systemic treatment with corticosteroids (> 10mg daily prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of the study drug. In the absence of active autoimmune disease, use > 10mg of daily prednisone equivalent doses of inhaled or topical steroids and adrenal substitute steroids; 12) The presence of past or current non-infectious pneumonia/interstitial lung disease (including radiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results of Imaging examinations ; | — |
Countries
China
Contacts
Public ContactYian Du
Zhejiang Cancer Hospital
Outcome results
None listed