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Trial Title:
Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer
NCT ID:
NCT06440811
Condition:
Gastric Cancer
Immune-related Adverse Event
Chemotherapeutic Toxicity
Conditions: Official terms:
Stomach Neoplasms
Nivolumab
Antibodies
Immunoglobulins
Conditions: Keywords:
neoadjuvant chemotherapy
Nivolumab
SOX
FLOT
deficient Mismatch Repair
locally advanced
Study type:
Interventional
Study phase:
Phase 1
Overall status:
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+PD-1 antibody
Description:
Patients would be allocated to the SOX+PD-1 antibody group.
Arm group label:
SOX+PD-1 antibody
Other name:
SOX+Nivolumab
Intervention type:
Drug
Intervention name:
FLOT+PD-1 antibody
Description:
Patients would be allocated to the FLOT+PD-1 antibody group
Arm group label:
FLOT+PD-1 antibody
Other name:
FLOT+Nivolumab
Summary:
The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX
regimen combined with PD-1 antibody versus FLOT Regimen with PD-1 antibody in localized
deficient mismatch repair gastric cancer. The main question it aims to answer are:
- Safety and efficacy of preoperative adjuvant SOX regimen combined with PD-1 antibody
versus FLOT regimen with PD-1 antibody for the treatment of localized deficient
mismatch repair gastric cancer
- Disease-free survival of preoperative adjuvant SOX plus PD-1 antibody and FLOT plus
PD-1 antibody for dMMR and locally advanced gastric cancer.
Participants will be divided into two groups to use a FLOT chemotherapy regimen plus PD-1
antibody and a SOX chemotherapy regimen plus PD-1 antibody.
Researchers would compare tumor regression grade, adverse effects and survival benefit of
two preoperative adjuvant regimens.
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:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tangdu hospital
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Shaanxi Provincial People's Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiawei Song, Doctor
Phone:
15281929912
Email:
15281929912@163.com
Facility:
Name:
Xijing hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Jipeng Li
Phone:
+86-029-84771533
Start date:
January 1, 2024
Completion date:
March 1, 2025
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/NCT06440811
