Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07315750

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.

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, BJ-Beijing, 100021, China

Location status: Recruiting

Location contact

Lin shen

CONTACT

[email protected]

86+010-88196561

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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; or disease progression or recurrence occurring ≥6 months after completion of neoadjuvant/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 test within 7 days prior to the first treatment, and agree not to breastfeed or donate ova from the signing of the informed consent form until 6 months after the last treatment. Male subjects must agree not to donate sperm from the signing of the informed consent form until 6 months after the last treatment.
  • Able to understand the study requirements and willing to comply with the study and follow-up procedures

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, or absorption
  • 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 expected to be cured with treatment
  • Pregnant or breastfeeding women

Treatment and study plan

Disitamab Vedotin

Drug

Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W;

Tislelizumab

Drug

Tislelizumab: 200 mg, IV, D1, Q3W

CAPOX (oxaliplatin/capecitabine)

Drug

Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W;

Trastuzumab

Drug

Trastuzumab: Initial dose of 8mg/kg, followed by 6 mg/kg, IV, D1, Q3W;

Pembrolizumab

Drug

Pembrolizumab: 200mg, IV, D1, Q3W

Primary outcomes

  1. Progression-Free Survival (assessed by the BIRC)

    Time frame: 24 months

    Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 as assessed by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Overall Survival

    Time frame: up to 5 years

    Overall survival (OS) refers to the time from the date of randomization to the date of death from any cause.

  2. Progression-Free Survival (assessed by the investigator)

    Time frame: 24 months

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigators or death due to any cause, whichever occurs first.

  3. Objective Response Rate (assessed by the BIRC and investigators)

    Time frame: 24 months

    ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 as assessed by BICR and investigators .

  4. Disease Control Rate (assessed by the BIRC and investigators)

    Time frame: 24 months

    DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1 as assessed by BICR/ investigators .

  5. Duration of Response (assessed by the BIRC and investigators)

    Time frame: 24 months

    For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first.

  6. Patient-Reported Outcomes (EORTC-QLQ-C30)

    Time frame: 24 months

    The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.

  7. Patient-Reported Outcomes (EORTCQLQ-STO22)

    Time frame: 24 months

    Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) STO22. It will be evaluated at Screening and Tumor Assessment Visit. The higher score means the worse quality of life.

  8. Patient-Reported Outcomes (EQ-5D-5L)

    Time frame: 24 months

    EQ-5D-5L is a standardized instrument for use as a measure of health outcomes consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.It was developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.

  9. Adverse Events

    Time frame: 24 months

    Incidence, severity, and relationship to the investigational product of adverse events (AEs) and serious adverse events (SAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Hongfang Li

CONTACT

[email protected]

86+010-65018841

Sponsors and collaborators

Lead sponsor

RemeGen Co., Ltd.

Industry

Registry information

Official study title

A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 2, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.