Preoperative Adjuvant SOX Plus PL-1 Antibody and FLOT Plus PD-1 Antibody for Locally Advanced dMMR Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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: a Chinese Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440811
• Other study ID #: loong-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2023
• Source: Xijing Hospital
• Contact: Jipeng Li, Doctor
• Phone: 13991316190
• Email: jipeng1974[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Gastric Cancer
• Immune-related Adverse Event
• Stomach Neoplasms

Intervention

Drug:
• SOX+PD-1 antibody
Patients would be allocated to the SOX+PD-1 antibody group.
• FLOT+PD-1 antibody
Patients would be allocated to the FLOT+PD-1 antibody group

Locations

Country	Name	City	State
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	Tangdu hospital	Xi'an	Shaanxi
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse event	adverse event caused by FLOT, SOX or PD-1 antibody 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
Secondary	tumor regression grade	Residual tumor components in post-radiotherapy samples and the proportion of fibrosis	From the surgery to evaluation of tumor regression grade, assessed up to 1 week
Secondary	disease-free survival	from diagnosis to recurrence or death	From date of diagnosis until the first documented recurrence or death, assessed up to 120 months
Secondary	objective response rate	objective response rate defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST).	From the surgery to evaluation of objective response rate, assessed up to 1 week
Secondary	Duration of response	Duration of response	From the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause, assessed up to 120 months.