Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

October 9, 2024 updated by: Xijing Hospital

Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Age >=18 years and <100 years.
  • 2. Diagnosed with locally advanced gastric cancer.
  • 3. Eastern Cooperative Oncology Group ECOG PS score 0-1.
  • 4. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.
  • 5. deficient mismatch repair identified by pathological detection.

Exclusion Criteria:

  • 1. Locally advanced unable to resect or metastatic tumors.
  • 2. Patients with recurrence of residual gastric cancer
  • 3. Patients refusing surgical resection after preoperative chemotherapy therapy.
  • 4. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
  • 5. Patients with confirmed allergy to the study drug and/or its excipients.
  • 6. Severe malnutrition and active autoimmune diseases.
  • 7. Pregnant or lactating women.
  • 8. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.
  • 9. Patients with acute infections requiring antibiotic treatment.
  • 10. Patients with acute infections requiring antibiotic treatment.
  • 11. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.
  • 12. Positive test result for hepatitis B or hepatitis C virus.
  • 13. Untreated central nervous system metastatic peripheral neuropathy (>grade 1).
  • 14. History of malignancy within the past 5 years (with the exception of curative, localized cancer).
  • 15. Patients who are not expected to achieve R0 resection.
  • 16. Weight loss greater than or equal to 20% within 4 weeks before the first dose.
  • 17. Patients with multiple factors affecting oral medication.
  • 18. Vaccination within 4 weeks prior to the first dose of study drug.
  • 19. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.
  • 20. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FLOT+Sintilimab
Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Sintilimab: 200 mg every 3 weeks.
Drug: FLOT+Sintilimab
Patients would be allocated to the FLOT+Sintilimab group.
Experimental: SOX+Sintilimab
Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Sintilimab: 200 mg every 3 weeks.
Drug: SOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of radical (R0) resection after neoadjuvant therapy
Time Frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.
From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse event
Time Frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
adverse event caused by FLOT, SOX or Sintilimab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events
From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
disease-free survival
Time Frame: From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
from diagnosis to recurrence or death
From date of diagnosis until the first documented recurrence or death, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • loong-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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