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)

NCT ID: NCT05466019

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-12-01

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) .

Conditions

PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab combined with FLOT regimen

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.

Group Type: EXPERIMENTAL

Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)

Intervention Type: 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.

Interventions

Drug: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Quan Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Quan Wang, phD

Role: primary

wquan@jlu.edu.cn

15843073207

Other Identifiers

STARS-GC04

Identifier Type: -

Identifier Source: org_study_id