A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Last updated: January 20, 2026
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Digestive System Neoplasms

Stomach Cancer

Gastric Ulcers

Treatment

CAPOX (oxaliplatin/capecitabine)

Tislelizumab

Pembrolizumab

Clinical Study ID

NCT07315750
RC48-C040
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma with HER2-high Expression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntarily consent to participate in the study and sign the informed consent form

  • Expected survival period >12 weeks

  • ECOG Performance Status 0 or 1

  • Histologically confirmed unresectable locally advanced or metastatic --gastric/gastroesophageal junction adenocarcinoma

  • No prior systemic therapy for locally advanced or metastatic gastric cancer; ordisease progression or recurrence occurring ≥6 months after completion ofneoadjuvant/adjuvant therapy

  • HER2-high expression

  • At least one assessable lesion according to RECIST v1.1 criteria

  • Adequate organ function

  • Female subjects of childbearing potential must have a negative blood pregnancy testwithin 7 days prior to the first treatment, and agree not to breastfeed or donateova from the signing of the informed consent form until 6 months after the lasttreatment. Male subjects must agree not to donate sperm from the signing of theinformed consent form until 6 months after the last treatment.

  • Able to understand the study requirements and willing to comply with the study andfollow-up procedures

Exclusion

Exclusion Criteria:

  • Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis

  • Peripheral neuropathy > Grade 1

  • Tumor lesions with a tendency to bleed

  • Severe gastrointestinal dysfunction that may affect drug intake, transport, orabsorption

  • Bone metastases with a risk of paraplegia

  • Past or current interstitial lung disease, or severely impaired lung function

  • Other malignancies within 5 years prior to randomization, except for those expectedto be cured with treatment

  • Pregnant or breastfeeding women

Study Design

Total Participants: 555
Treatment Group(s): 5
Primary Treatment: CAPOX (oxaliplatin/capecitabine)
Phase: 3
Study Start date:
January 01, 2026
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Beijing Cancer Hospital

    Beijing 1816670, BJ-Beijing 100021
    China

    Active - Recruiting

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