Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SOX+Sintilimab, FLOT+Sintilimab.
- Who it may be relevant to
- Registry conditions: Neoadjuvant Chemotherapy, Sintilimab, Locally Advanced Gastric Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- Drug SOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group. - Drug FLOT+Sintilimab
Patients would be allocated to the FLOT+Sintilimab group.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- adverse event [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06459921 · loong-201