NCT06944496

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of \*\*Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX\*\* as first-line treatment for patients with HER2-low advanced gastric or gastroesophageal junction adenocarcinoma.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
616

participants targeted

Target at P75+ for phase_3

Timeline
49mo left

Started May 2025

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
May 2025May 2030

First Submitted

Initial submission to the registry

April 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

May 15, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2030

Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

April 17, 2025

Last Update Submit

April 23, 2025

Conditions

Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    24 months

Secondary Outcomes (6)

  • Overall Survival

    up to 5 years

  • Objective Response Rate

    24 months

  • Disease Control Rate

    24 months

  • Duration of Response

    24 months

  • Patient-Reported Outcomes

    24 months

  • +1 more secondary outcomes

Study Arms (2)

Tislelizumab combined with CAPOX

ACTIVE COMPARATOR
Biological: Tislelizumab+Oxaliplatin+Capecitabine

Disitamab Vedotin Combined with Tislelizumab and CAPOX

EXPERIMENTAL
Biological: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine

Interventions

Disitamab Vedotin+Tislelizumab+Oxaliplatin+CapecitabineBIOLOGICAL

Disitamab Vedotin: 2.5 mg/kg, IV, D1, Q2W; Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 100 mg/m², IV, D1, Q3W; Capecitabine: 750 mg/m², po, BID, D1-D14, Q3W

Disitamab Vedotin Combined with Tislelizumab and CAPOX
Tislelizumab+Oxaliplatin+CapecitabineBIOLOGICAL

Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W

Tislelizumab combined with CAPOX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, metastatic, or recurrent gastric or gastroesophageal junction adenocarcinoma
  • No prior systemic therapy for locally advanced or metastatic gastric cancer
  • HER2-low expression
  • At least one assessable lesion according to RECIST v1.1 criteria
  • Adequate organ function
  • For female subjects: They should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment. A blood pregnancy test must be negative within 7 days before the study medication is administered, and they must not be breastfeeding
  • For male subjects: They should be surgically sterilized or agree to use a medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment
  • Able to understand the study requirements and willing to comply with the study and follow-up procedures

You may not qualify if:

  • Presence of central nervous system (CNS) metastasis and/or carcinomatous meningitis
  • Peripheral neuropathy \> Grade 1
  • Tumor lesions with a tendency to bleed
  • Uncontrolled diarrhea
  • Bone metastases with a risk of paraplegia
  • Past or current interstitial lung disease, or presence of drug-induced pneumonia, radiation pneumonia, or severely impaired lung function
  • Other malignancies within 5 years before the first dose, except for those expected to be cured with treatment (e.g., adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, BJ-Beijing, 100021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

SU Xiaohong Study Director, M.D

CONTACT

+0810-65391479xiaohong.su@remegen.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 25, 2025

Study Start

May 15, 2025

Primary Completion (Estimated)

May 15, 2028

Study Completion (Estimated)

May 15, 2030

Last Updated

April 25, 2025

Record last verified: 2025-04

Locations

CN(1)