gastric cancer
Conditions
Interventions
Treatment group:Adebenone 1200 mg, IV drip, Day 1, every 3 weeks
Tegafur 40 mg/m^2, daily, Days 1-14, every 3 weeks
Oxaliplatin 130 mg/m^2, IV drip, Day 1, every 3 weeks
Apatinib 250 mg, daily
a total of 4 cycles, with apatinib discontinued on the last 28 days.
After conversion therapy, the patient underwent surgery and was given the following treatment: Tegafur 40 mg/m^2, qd, d1-14, q3w
Oxaliplatin 130 mg/m^2, IV drip, d1, q3w
and four cycles of adjuvant chemotherapy.
Postoperatively, patients were given Adebelimumab 1200 mg, IV drip, Day 1, every 3 weeks
Apatinib 250 mg, once daily
maintenance therapy was continued until the patient could not tolerate the medication, the disease progressed, or the medication was continued for two years.
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Age 18-75, gender not limited; 2. Patients with gastric cancer diagnosed by pathology or cytology and with PD-L1 CPS >= 1 and borderline resectable: tumor stage T4b with fused lymph nodes, or patients with isolated liver metastases; 3. According to the RECIST 1.1 criteria for evaluating the efficacy of treatment for solid tumors, the patient must have at least one measurable lesion, which should not have received local treatment such as radiotherapy; 4. ECOG score: 0-1; 5. Expected survival >= 12 weeks; 6. Pre-excisable tumor tissue is available; 7. The patient has not previously received any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 8. Sufficient organ function; subjects must meet the following laboratory indicators: (1) In the absence of granulocyte colony-stimulating factor use in the past 14 days, the absolute neutrophil count (ANC) is >= 1.5 x 10^9/L; (2) Platelet count >= 100 x 10^9/L if no blood transfusion has been given in the past 14 days; (3) Hemoglobin > 9 g/dL in the absence of blood transfusion or erythropoietin use within the past 14 days; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH exceeding the normal range may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; (9) Cardiac enzyme levels are within the normal range (simply laboratory abnormalities that are not clinically significant, as determined by the researchers, are also allowed to be included in the study); 9. For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to the first dose of the study drug (day 1 of cycle 1), and the result should be negative. If the urine pregnancy test result is not confirmatory, a blood pregnancy test is required. Women of reproductive age are defined as those who have been postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; 10. If there is a risk of pregnancy, all subjects (whether male or female) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug); 11. Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will not be eligible to participate in this study: 1. BMI = 10% within 2 months prior to screening (the impact of large amounts of ascites on weight should also be considered); 2. History of gastrointestinal perforation and/or fistula within 6 months prior to first use of medication; 3. History of allergy to any component of adebelimumab, oxaliplatin, tegafur, or apatinib; 4. Have received any of the following treatments: (1) Has previously received anti-PD-1 or anti-PD-L1 antibody therapy; (2) Has received any investigational drug within 4 weeks prior to first use of this drug; (3) Enrollment in another clinical study simultaneously, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; (4) Received the last dose of anticancer treatment (including radiotherapy) within 10 mg prednisone daily) or other immunosuppressants within 2 weeks prior to first use of the investigational drug; (6) Individuals who have received anti-tumor vaccines or who have received live vaccines within 4 weeks prior to the first administration of the investigational drug; (7) Individuals who have undergone major surgery or suffered trauma within 4 weeks prior to the first use of the investigational drug; 5. Patients whose previous antitumor treatment toxicity has not recovered to 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging showed active lung inflammation; symptoms and signs of infection existed within 2 weeks prior to the first use of the study drug; or oral and intravenous antibiotics were required, excluding prophylactic antibiotic use; 10. History of interstitial lung disease (excluding radiation-induced pneumonia not treated with hormones) or non-infectious pneumonia; 11. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis interference more than 1 year ago but without regular treatment; 12. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of disease;Pathological complete remission rate;Overall Survival;adverse event; | — |
Countries
China
Contacts
Public ContactXu Tao
Shandong Provincial Hospital
Outcome results
None listed