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Trial Title:
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer
NCT ID:
NCT06459921
Condition:
Neoadjuvant Chemotherapy
Sintilimab
Locally Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
SOX+Sintilimab
Description:
Patients would be allocated to the SOX+Sintilimab group.
Arm group label:
SOX+Sintilimab
Intervention type:
Drug
Intervention name:
FLOT+Sintilimab
Description:
Patients would be allocated to the FLOT+Sintilimab group.
Arm group label:
FLOT+Sintilimab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06459921
