RecruitingPhase 2NCT07194005

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


Sponsor

Fudan University

Enrollment

30 participants

Start Date

Sep 4, 2025

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment — an antibody-drug conjugate (RC48), an immunotherapy drug (sintilimab), and a chemotherapy regimen (SOX) — to try to shrink HER2-expressing gastric or gastroesophageal cancer enough that it becomes operable ("conversion therapy") in patients whose cancer is currently unresectable. **You may be eligible if...** - You are between 18 and 70 years old with confirmed, unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer - Your tumor shows HER2 expression of IHC 1+ or 2+ (lower levels of HER2) - You have not received any prior systemic anticancer therapy - There is only one factor making your tumor unresectable at this time - You have at least one measurable tumor lesion and your expected survival is at least 6 months - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have received any prior chemotherapy or systemic cancer treatments - Your tumor does not express HER2 - Your tumor has multiple factors making it unresectable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab vedotin(RC48)

2.5 mg/kg, administered intravenously every 3 weeks (Q3W) on Day 1 of each cycle.

DRUGSintilimab

200 mg, administered intravenously, d1, every 3 weeks.

DRUGS-1

Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks.

DRUGOxaliplatin

130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07194005


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