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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) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab combined with FLOT regimen | Experimental | The enrolled patients will receive 3 cycles of FLOT regimen +Toripalimab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). After completing the 3 cycles of treatment, the patient undergoes surgical resection.Toripalimab combined with FLOT regimen were maintained for 4 cycles after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival (EFS) | 2 years | |
| disease-free survival (DFS) | 2 years | |
| overall survival (OS) |
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Inclusion Criteria:
Informed consent of the patient;
18 years old <age <75 years old;
The researcher judged that he could comply with the study protocol;
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);
Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)
Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1);
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;
Preoperative ASA score I-III;
Expected survival ≥12 weeks;
The baseline blood routine and biochemical parameters of selected patients should meet the following criteria:
Exclusion Criteria:
Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma
Previous systemic treatment for gastric cancer
Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine;
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;
History of other malignant diseases within 5 years;
History of active autoimmune disease or autoimmune disease
The subject has cardiovascular clinical symptoms or disease that is not well controlled;
Severe infection 4 weeks prior to first use of study drug (CTCAE > Level 2)
A history of interstitial lung disease (except for radiation pneumonia not treated with Chinese hormone) or non-infectious pneumonia;
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;
Pregnant or lactating women;
Suffering from severe mental illness.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| 2 years |
| objective response rate (ORR) | 3 months |
| R0 Surgical conversion rate | 3 months |
| major pathological response (MPR) | 3 months |
| 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 |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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