Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT V... | NCT06459921

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLOT+Sintilimab	Active Comparator	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
SOX+Sintilimab	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
SOX+Sintilimab	Drug	Patients would be allocated to the SOX+Sintilimab group.	SOX+Sintilimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of radical (R0) resection after neoadjuvant therapy	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 Outcomes

Measure	Description	Time Frame
adverse event	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

Eligibility Module

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.

Name	Role	Phone	Extension	Email
Jipeng Li, Doctor	Contact	13991316190		jipeng1974@aliyun.com
Yihuan Qiao, Doctor	Contact	18682986362		yhqiao1995@126.com