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
Fudan University
30 participants
Sep 4, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
2.5 mg/kg, administered intravenously every 3 weeks (Q3W) on Day 1 of each cycle.
200 mg, administered intravenously, d1, every 3 weeks.
Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks.
130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.
Locations(1)
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NCT07194005