Efficacy and Safety of Neoadjuvant Nivolumab Plus SOX Versus Nivolumab Plus FLOT in Patients With HER2-negative Gastric and Gastroesophageal Junction Adenocarcinoma

NCT06440811 | Completed DMC

• 1 other identifier: loong-101
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the study is to learn about Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT Regimen with nivolumab in HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. The main question it aims to answer are:

• Safety and efficacy of preoperative adjuvant SOX regimen combined with nivolumab versus FLOT regimen with nivolumab for the treatment of HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma.
• Disease-free survival of preoperative adjuvant SOX plus nivolumab and FLOT plus nivolumab for HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma. Participants will be divided into two groups to use a FLOT chemotherapy regimen plus nivolumab (one group) and a SOX chemotherapy regimen plus nivolumab (another group). Researchers would compare tumor regression grade, adverse effects and survival benefit of two neoadjuvant regimens.

Conditions

Immune-related Adverse Event; Chemotherapeutic Toxicity; Gastric or Gastroesophageal Junction Adenocarcinoma

Keywords

neoadjuvant chemotherapy; Nivolumab; SOX; FLOT; locally advanced; HER-negative

Outcome Measures

Primary Outcomes (1)

• adverse event

  adverse event caused by FLOT, SOX or nivolumab 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 Outcomes (4)

• tumor regression grade

  From the surgery to evaluation of tumor regression grade, assessed up to 1 week

• disease-free survival

  From date of diagnosis until the first documented recurrence or death, assessed up to 120 months

• objective response rate

  From the surgery to evaluation of objective response rate, assessed up to 1 week

• 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.

Study Arms (2)

FLOT+nivolumab

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 oxaliplatin 85 mg/m² intravenous docetaxel 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses).

SOX+nivolumab

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. Nivolumab (360 mg) was administered intravenously (IV) over 30 minutes once every 3 weeks for 6 weeks (1 cycle, 2 doses).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients came from several tertiary hospitals in Xi'an city, Shaanxi Province, and were diagnosed with locally advanced gastric cancer, and the patients would accept either the neoadjuvant SOX+nivolumab or FLOT+nivolumab regimen.

You may qualify if:

• \. Histopathological confirmation of GC or GEJC.
• \. Absence of prior anti-tumor treatments, encompassing surgical resection, chemotherapy, radiotherapy, or immunotherapy.
• \. Age within the range of 18 to 75 years.
• \. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
• \. Absence of concurrent malignancies.
• \. For patients with resectable GC, those with locally advanced stage III and IVA were clearly included according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system, and there were no unresectable factors.
• \. Patients with HER-2 negative.
• \. Basal information such as hematology and pathological histology was complete.

You may not qualify if:

• \. Refusal of surgical resection subsequent to neoadjuvant therapy.
• \. Receipt of other ICIs during the study period.
• \. Receipt of corticosteroids during the study period.
• \. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.
• \. Confirmed recurrence of GC.
• \. Hypersensitivity to the study medication.
• \. Systemic medical conditions contraindicating chemotherapy.
• \. Psychiatric illnesses contraindicating chemotherapy.
• \. Acute infections necessitating antibiotic therapy.
• \. Uncontrolled diabetes mellitus.
• \. Metastatic disease.
• \. Severe malnutrition.
• \. Active autoimmune disorders.
• \. Pregnancy or lactation.
• \. Positive serological test for hepatitis B or C virus infection,

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (3)

Tangdu hospital

Xi'an, Shaanxi, 710032, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Location

Xijing hospital

Xi'an, Shaanxi, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissues and adjacent tissues were obtained from every patient in these two cohorts. Thess tissues would be used for pathological histologyfor (Hematoxylin and eosin (H\&E)) and cluadin18.2 identified by Immunohistochemistry (IHC) and tertiary lymphoid structures (TLS) identified by Immunofluorescence.

Study Officials

• Jipeng Li, Doctor

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: June 4, 2024
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 30, 2022
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)