Toripalimab Combined With FLOT Neoadjuvant Chemotherapy in Patients With Resectable Gastric Cancer

NCT04354662 | Unknown Phase 2

• 1 other identifier: Gastrim 001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate. Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis. The AIO-FLOT4 study found that preoperative perioperative FLOT chemotherapy not only prolonged the progression-free survival (PFS) time and overall survival (OS) time of patients with advanced gastric cancer, but also increased postoperative pathological remission rate. How to further improve the efficacy of the perioperative treatment plan may be beneficial to improve the long-term survival of gastric cancer patients. Several clinical studies have also confirmed that PD-1 antibody significantly prolongs the life of gastric cancer patients who have failed advanced chemotherapy in the back-line treatment. Thus the investigators plan to conduct this clinical trials to evaluate the safety and efficacy of Toripalimab (PD-1 antibody) combined with FLOT regimen in the perioperative period.The secondary end points included pathological remission rate, resection rate, D2 radical resection rate, 5-year disease-free survival (DFS) rate and 5-year OS rate.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Neoadjuvant Chemotherapy; Immunotherapy; Toripalimab; Pathological Remission

Outcome Measures

Primary Outcomes (2)

• 3-year Disease-Free Survival Rate

  The primary end point of the study is the effect of perioperative time flot regimen combined with Toripalimab and D2 radical operation on the 3-year disease-free survival time of resectable gastric cancer.

  Up to 3 years

• Pathological complete response rate (pCR)

  Proportion of patients with gastric cancer who received Toripalimab combined with FLOT regimen after 4 cycles of neoadjuvant therapy and postoperative pathological examination TRG1a

  Up to 6 months

Secondary Outcomes (4)

• Major pathological (complete and nearly complete) response (MPR)

  Up to 6 months

• Adverse Events

  Up to 6 months

• 5-year Disease-Free Rate

  Up to 5 years

• 5-year Survival Rate

  Up to 5 years

Study Arms (1)

Toripalimab combined with FLOT

EXPERIMENTAL

In the perioperative period, patients with resectable gastric cancer is treated with flot regimen combined with Toripalimab to observe whether the 3-year disease-free survival (DFS) rate, pathological remission rate, R0 resection rate, D2 radical resection rate, 5-year DFS rate and 5-year OS rate could be improved.

Drug: Toripalimab; Drug: Docetaxel; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

Toripalimab DRUG

240mg d1

Also known as: JS001

Toripalimab combined with FLOT

Docetaxel DRUG

50mg/m2, d1;

Toripalimab combined with FLOT

Fluorouracil DRUG

2600 mg/m², d1

Toripalimab combined with FLOT

Leucovorin DRUG

200 mg/m², d1

Toripalimab combined with FLOT

Oxaliplatin DRUG

85 mg/m², d1

Toripalimab combined with FLOT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• locally advanced (\>T1) and/or nodal positive (N+) histologically proven adenocarcinoma of the gastric or gastroesophageal junction without distant metastases (M0)
• no previous surgical resection
• no previous cytostatic chemotherapy
• Age \> 18 years, no more than 75 years (female and male)
• Karnofsky Performance Status score of physical condition is 80-100
• surgical resectability
• Leucocytes \> 4.000/µl
• Platelets \> 100.000/µl
• Serum creatinin ≤ 1.5x of normal value, or Creatinin-Clearance \> 50 ml/min
• written informed consent.

You may not qualify if:

• Distant metastasis or local invasion of adjacent organs;
• Recurrent or residual gastric cancer;
• Having or having had autoimmune disease;
• Previous organ transplantation or HIV patients;
• Allergy or contraindications to Toripalimab, 5- Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel;
• Malignant secondary disease;
• Severe non-surgical disease or acute infection;
• Peripheral polyneuropathy \> NCI grad I;
• Blood system, liver and kidney function were damaged;
• Symptomatic brain metastasis;
• Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency and severe gravity valve disease;
• Psychotic subjects who are not easy to control;
• Pregnant or lactating subjects.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

toripalimab; Docetaxel; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes

Study Officials

• Hongli Li, Dr

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Li, Dr

CONTACT

8618622221233; hongli@126.com

Jinyu Deng, Dr

CONTACT

8618622228656

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, non-randomized, phase II clinical trial

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: September 26, 2019
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2024
• Last Updated: February 18, 2021

Record last verified: 2021-01

Locations

CN (1)