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A Real-World, Single-Arm Study Protocol of Disitamab Vedotin in Combination With Immunotherapy and Multimodal Radiation Therapy for HER2-Positive Advanced Gastric Cancer: After Second-Line Treatment Failure

NCT07490990 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-24

No results posted yet for this study

Summary

Patients with HER2-positive advanced gastric cancer who have failed standard first-line and second-line therapies have limited treatment options. Disitamab vedotin, a novel anti-HER2 antibody-drug conjugate, has been approved in China for this patient population. Additionally, immune checkpoint inhibitors (ICIs) have become a cornerstone of treatment for advanced gastric cancer, but disease progression or immune-related adverse events often lead to treatment discontinuation, raising the clinical question of immunotherapy rechallenge. Preclinical and early clinical evidence suggests that disitamab vedotin may modulate the tumor immune microenvironment and synergize with PD-1 blockade. Furthermore, multimodality radiotherapy (MMRT), combining low-dose radiotherapy (LDRT) and stereotactic body radiotherapy (SBRT), may enhance systemic anti-tumor responses by releasing tumor antigens and remodeling the immune microenvironment.

This prospective, single-center, multicenter, non-interventional study aims to evaluate the efficacy and safety of disitamab vedotin in combination with PD-1 inhibitor immunotherapy and multimodality radiotherapy in patients with HER2-positive advanced gastric cancer after failure of first- and second-line treatment. Eligible patients will receive disitamab vedotin and PD-1 inhibitor per standard clinical guidelines, followed by MMRT targeting at least two independent lesions. The primary endpoint is progression-free survival (PFS) assessed by RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety profile. Exploratory biomarker analyses will be conducted using tumor tissue and peripheral blood samples. A total of 30 patients will be enrolled. This study is conducted in compliance with the Declaration of Helsinki and relevant Chinese regulations, with approval from the West China Hospital Ethics Committee and written informed consent from all participants.

Conditions

  • HER2-positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Interventions

DRUG

Disitamab vedotin + Sintilimab + Multimodality radiotherapy

Disitamab vedotin (generic name; code: RC48; Chinese name: 维迪西妥单抗): Administered per Chinese clinical practice guidelines for HER2-overexpressing advanced gastric cancer, via intravenous infusion at the recommended dosage and interval (e.g., 2.5 mg/kg every 2 weeks, adjusted for patient tolerance). Sintilimab (generic name; Chinese name: 信迪利单抗): A PD-1 monoclonal antibody administered according to routine clinical practice, via intravenous infusion at the standard dosage and cycle (e.g., 200 mg every 3 weeks, continued until disease progression or unacceptable adverse events). Multimodal radiotherapy (MMRT): Initiated after the first cycle of systemic therapy (disitamab vedotin + sintilimab), consisting of two distinct irradiation strategies for separate independent lesions. Specific regimens are determined by the radiation oncologist based on individual patient conditions (including lesion location/size, organs at risk, and other relevant factors): Low-dose Radiotherapy (LDRT): ≥ 1

Sponsors & Collaborators

  • Jiangsu Taizhou People's Hospital

    collaborator OTHER

  • Chengdu First People's Hospital

    collaborator OTHER

  • West China Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490990 on ClinicalTrials.gov