NCT07194005

Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer

Efficacy and Safety of RC48 (Disitamab Vedotin) Combined With Sintilimab and SOX for HER2 IHC 1+/2+ Unresectable Locally Advanced or Advanced Gastric Cancer Conversion Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.

Detailed description

This is an open-label, single-arm, exploratory study designed to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ locally advanced or metastatic gastric cancer. The primary objective is to assess the efficacy of the combination regimen based on the R0 resection rate. Tumor response will be evaluated every 6 to 12 weeks via imaging to determine whether surgical criteria are met. Patients who meet the criteria for operability will proceed to surgery, and postoperative adjuvant therapy will be tailored by the investigator based on individual patient conditions. For those who do not achieve successful conversion, the investigator will decide whether to continue the original treatment or transition to an alternative therapeutic strategy.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Disitamab vedotin(RC48)	2.5 mg/kg, administered intravenously every 3 weeks (Q3W) on Day 1 of each cycle.
DRUG	Sintilimab	200 mg, administered intravenously, d1, every 3 weeks.
DRUG	S-1	Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks.
DRUG	Oxaliplatin	130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.

Timeline

• Start date: 2025-09-04
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: China