PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer
Conditions
Brief summary
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .
Interventions
DRUGDrug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)
FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ, Q2W Toripalimab 3mg/kg, intravenously administered on the first day of each cycle, Q2W.
Sponsors
The First Hospital of Jilin University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent of the patient; 2. 18 years old \<age \<75 years old; 3. The researcher judged that he could comply with the study protocol; 4. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III); 5. Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th) * Esophagogastroduodenoscopy must be performed * Diagnostic laparoscopy must be performed 6. Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1); 7. Preoperative ECOG \[Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)\] Physical State Score 0/1; 8. Preoperative ASA score I-III; 9. Expected survival ≥12 weeks; 10. The baseline blood routine and biochemical parameters of selected patients should meet the following criteria: * Hemoglobin ≥90g/ L, which can be met by blood transfusion; * Absolute neutrophil count ≥1.5×10\^9/ L * Platelet count ≥100×10\^9/ L * Aspartic acid or alanine aminotransferase ≤ 2.5 times the upper limit * Alkaline phosphatase ≤ 2.5 times normal upper limit (ULN), * Thyroid stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time; if T3 and T4 levels are normal, they can be included in the group);
Exclusion criteria
1. Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma 2. Previous systemic treatment for gastric cancer 3. Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine; 4. Received any of the following medical treatment: A. Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past; B. Have received any investigational drug treatment within 4 weeks before using the drug for the first time; C. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; D. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;; E. Receive systematic treatment with corticosteroids (\> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to their first use of the study drug; F. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; G. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time; 5. History of other malignant diseases within 5 years; 6. History of active autoimmune disease or autoimmune disease 7. The subject has cardiovascular clinical symptoms or disease that is not well controlled; 8. Severe infection 4 weeks prior to first use of study drug (CTCAE \> Level 2) 9. A history of interstitial lung disease (except for radiation pneumonia not treated with Chinese hormone) or non-infectious pneumonia; 10. Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 year ago but without formal treatment; 11. Pregnant or lactating women; 12. Suffering from severe mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival (DFS) | 2 years |
| overall survival (OS) | 2 years |
| objective response rate (ORR) | 3 months |
| R0 Surgical conversion rate | 3 months |
| event-free survival (EFS) | 2 years |
| Incidence and severity of adverse events | 6 months |
| index of tumor-infiltrating lymphocyte (sTIL) infiltration | 3 months |
| type and number of intestinal flora | 3 months |
| major pathological response (MPR) | 3 months |
Countries
China
Outcome results
None listed