NCT04782791

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

A Prospective, Randomized, Controlled Phase II Evaluation of Nivolumab, S-1 Combined With Oxaliplatin (Nivo+SOX) Versus Nivolumab (Nivo) as Neoadjuvant Therapy in Patients With Locally Advanced Gastric Adenocarcinoma (RESONANCE-Ⅲ Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Cancer
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Nivolumab plus SOX	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.
DRUG	Nivolumab	The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1.
PROCEDURE	Gastrectomy	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-31
• Completion: 2024-05-31
• First posted: 2021-03-04
• Last updated: 2022-01-11