Locally Advanced Gastric Cancer, Neoadjuvant Chemotherapy, Sintilimab
Conditions
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.
Interventions
DRUGSOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group.
DRUGFLOT+Sintilimab
Patients would be allocated to the FLOT+Sintilimab group.
Sponsors
Xijing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of radical (R0) resection after neoadjuvant therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| adverse event | 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 |
| disease-free survival | From date of diagnosis until the first documented recurrence or death, assessed up to 60 months | from diagnosis to recurrence or death |
Contacts
Primary ContactJipeng Li, Doctor
Backup ContactYihuan Qiao, Doctor
Outcome results
None listed