NCT05466019
Recruiting
Phase 2
Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ): a Prospective, Single-center Clinical Study
The First Hospital of Jilin University1 site in 1 country30 target enrollmentStarted: May 1, 2021Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pathological complete response (pCR)
Overview
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) .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
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;
Outcomes
Primary Outcomes
Pathological complete response (pCR)
Time Frame: 3 months
Secondary Outcomes
- 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)
- disease-free survival (DFS)(2 years)
Investigators
Quan Wang
Professor
The First Hospital of Jilin University
Study Sites (1)
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