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OncoMatch/Clinical Trials/NCT06487429

Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer

Is NCT06487429 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Short range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumab for gastric cancer.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT06487429Data as of Jun 2026Location: China

Treatment: Short range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumabThis study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Short range radiotherapy with sequential Disitamab Vedotin combined with S-1 and xindilizumab

Cancer type

Gastric Cancer

Biomarker criteria

Required: HER2 (ERBB2) expression (IHC1+, 2+, 3+) (IHC1+, 2+, or 3+)

IHC results confirm HER2 expression (defined as IHC1+, 2+, 3+)

Disease stage

Required: Stage CT3-4N+M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-HER2 therapy

Previously received the following therapies: anti-HER2

Cannot have received: anti-PD-1 therapy

Previously received the following therapies: anti-PD-1

Cannot have received: anti-PD-L1 therapy

Previously received the following therapies: anti-PD-L1

Cannot have received: anti-PD-L2 therapy

Previously received the following therapies: anti-PD-L2

Cannot have received: checkpoint inhibitor

drugs targeting another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.)

Cannot have received: systemic cytotoxic chemotherapy

Have not received systematic treatment for the current disease in the past, including anti-tumor radiotherapy, chemotherapy, immunotherapy, etc

Cannot have received: radiation therapy

Have not received systematic treatment for the current disease in the past, including anti-tumor radiotherapy, chemotherapy, immunotherapy, etc

Cannot have received: immunotherapy

Have not received systematic treatment for the current disease in the past, including anti-tumor radiotherapy, chemotherapy, immunotherapy, etc

Cannot have received: systemic traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect (thymosin, interferon, interleukin)

Exception: except for local use to control pleural effusion

Have received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration

Lab requirements

Blood counts

The main organs are functioning well

Kidney function

The main organs are functioning well

Liver function

The main organs are functioning well

The main organs are functioning well

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06487429 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 expression (IHC1+, 2+, 3+) is a required biomarker for enrollment.

What disease stage is eligible?

Stage CT3-4N+M0 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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