Gastric antral cancer and pyloric obstruction
Conditions
Interventions
Treatment group:Separated gastrojejunostomy+neoadjuvant therapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~75 years old, male or female; 2. Presence of histologically confirmed, untreated antral cancer; 3. Confirm pyloric obstruction by gastroscopy or upper gastrointestinal angiography before treatment; In the case of incomplete obstruction, the amount of food eaten (including ONS) decreases by more than 40%; 4. Before treatment, it is clear that cT3-4a, or/and N, M0 are confirmed by ultrasound, gastroscopy or CT and other examinations; 5. Laparoscopic exploration before treatment confirmed that there was no peritoneal implant metastasis (CY1/P1); 6. Have not received prior treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 7. ECOG: 0-1 points; 8. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg( ) or HBcAb ( ), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must < 1000 copies/mL or <200 IU/mL or < site upper limit of normal (ULN) for enrollment, HCV antibody (-); 9. Normal function of major organs, that is, meeting the following criteria (no blood transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factor (CSF) therapy within 14 days prior to enrollment); 10. Good cardiac function before enrollment, no myocardial infarction/cerebral infarction within half a year, hypertension and coronary heart disease are currently within the controllable range; 11. No other uncontrollable benign diseases such as lung, kidney, liver infection, etc. before enrollment; 12. Female patients must meet: Postmenopausal status (defined as no menses for at least 1 year and no confirmed cause other than menopause), or have undergone surgical sterilization (removal of ovaries and/or uterus), or patients of childbearing potential must meet the following requirements at the same time: 1) Serum pregnancy test result within 7 days prior to enrollment must be negative; 2) Agree to use contraception with an annual failure rate of <1% or remain abstinent (refrain from heterosexual intercourse) (from signing the informed consent form until at least 120 days after the last dose of the trial drug, and at least 6 months after the last dose of the chemotherapy drug (annual failure rate <1% of contraceptive methods include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices. 3) Do not breastfeed. Male patients must meet: Agree to abstinence (refrain from heterosexual intercourse) or use contraception, which is defined as follows: If the partner is a female of childbearing age or the partner is pregnant, the male patient must remain abstinent during chemotherapy treatment and for at least 6 months after the last dose of chemotherapy drug and for at least 120 days after the last dose of trial drug to prevent exposure to the embryo. The reliability of sexual abstinence should be assessed in light of the duration of clinical studies, patient preferences, and lifestyle of daily living. Regular abstinence (e.g., calendar day, ovulation, basal body temperature, or post-ovulation contraceptive methods) and in vitro ejaculation are ineligible methods of contraception. 13. Study participants voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with malignant diseases other than gastric cancer within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ); 2.Patients who are preparing for or have previously undergone organ or bone marrow transplantation; 3.Within the first 6 months of enrollment, there has been a myocardial infarction or poorly controlled arrhythmia (including QTc interval >= 450ms for males and >=470ms for females) (QTc interval calculated using Fridericia's formula); 4.There is NYHA standard grade III-IV cardiac dysfunction or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)10mg/day effective dose of prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 11.Within 14 days prior to enrollment, any active infections requiring systematic anti infective treatment have occurred; Except for receiving prophylactic antibiotic treatment (such as preventing urinary tract infections or chronic obstructive pulmonary disease); 12.Known history of severe allergy to any monoclonal antibody or research drug excipient; 13.Known history of abuse or drug use of psychotropic substances; Patients who have stopped drinking alcohol can be included in the group; 14.There is a possibility of increasing the risk of participation in research and research medication, or other severe, acute, and chronic diseases that the researchers have determined are not suitable for patients to participate in clinical research;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;Operation complications and drug complications;Major pathological response rate; | — |
Countries
China
Contacts
Public ContactXiao Shuomeng
Sichuan Cancer Hospital
Outcome results
None listed