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)

Phase 2

Recruiting

• Conditions: PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer

• Registration Number: NCT05466019
• Lead Sponsor: The First Hospital of Jilin University

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Primary Completion: 2024-05-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR)	3 months

Secondary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	2 years
overall survival (OS)	2 years
objective response rate (ORR)	3 months
index of tumor-infiltrating lymphocyte (sTIL) infiltration	3 months
event-free survival (EFS)	2 years
R0 Surgical conversion rate	3 months
major pathological response (MPR)	3 months
Incidence and severity of adverse events	6 months
type and number of intestinal flora	3 months

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Ji Lin, China