Nivolumab, S-1 Combined With Oxaliplatin Versus Nivolumab as Neoadjuvant Therapy in Advanced Gastric Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT04782791
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab plus SOX — DRUG
    The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg and oxaliplatin 130mg/m2 on day 1, and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): BSA\<1.25 m2, 40mg; 1.25\<BSA\<1.50 m2, 50mg; BSA\>1.50 m2, 60mg. Day 15 to day 21 is the rest period.
  • Nivolumab — DRUG
    The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1.
  • Gastrectomy — PROCEDURE
    A standard D2 radical laparoscopic gastrectomy according to the CSCO clinical guidelines for the diagnosis and treatment of gastric cancer is planned 3-4 weeks after the last cycle of preoperative therapy.

Study Details

The trial is a prospective, randomized, controlled phase Ⅱ study which will be conducted in Chinese PLA General Hospital, Beijing, China. Patients with eligibility will enrolled and assigned into either group A for 9 weeks of nivolumab, S-1 combined with oxaliplatin (Nivo+SOX) followed by D2 surgery and group B for 9 weeks of nivolumab followed by D2 surgery. The primary endpoint is the safety assessed by recording adverse events and the secondary endpoints are response rate, disease control rate, pathological complete response rate, D2 rate and R0 rate.

Key Dates

Start date
May 1, 2022
Status verified
Jan 2022
Primary completion
Dec 31, 2023
Completion
May 31, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivo + SOX
    Nivolumab plus SOX
  • Active Comparator: Nivo
    Nivolumab

Primary Outcome Measure

Adverse events [ Time Frame: 2 years ]

Central Contacts

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