Clinical trial NCT06459921: Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
Official title: Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Neoadjuvant Chemotherapy
Sintilimab
Locally Advanced Gastric Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of radical (R0) resection after neoadjuvant therapy
timeFrame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
Secondary outcomes:
measure: adverse event
timeFrame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
measure: disease-free survival
timeFrame: From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
Other outcomes:
Locations:
Study officials:
References: