A Prospective, Single Center Clinical Study of Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    30
  • sponsor
    The First Hospital of Jilin University
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Updated on 4 October 2022
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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) .

Details
Condition PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer
Treatment Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)
Clinical Study IdentifierNCT05466019
SponsorThe First Hospital of Jilin University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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)
Esophagogastroduodenoscopy must be performed
Diagnostic laparoscopy must be performed
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
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

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
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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