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NCT Number: NCT06459921

Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SOX+Sintilimab

Drug

Patients would be allocated to the SOX+Sintilimab group.

FLOT+Sintilimab

Drug

Patients would be allocated to the FLOT+Sintilimab group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jipeng Li, Doctor

CONTACT

[email protected]

13991316190

Yihuan Qiao, Doctor

CONTACT

[email protected]

18682986362

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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