A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
NCT ID: NCT06944496
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
616 participants
INTERVENTIONAL
2025-05-15
2030-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tislelizumab combined with CAPOX
Tislelizumab+Oxaliplatin+Capecitabine
Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W
Disitamab Vedotin Combined with Tislelizumab and CAPOX
Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine
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
Interventions
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Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine
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
Tislelizumab+Oxaliplatin+Capecitabine
Tislelizumab: 200 mg, IV, D1, Q3W Oxaliplatin: 130 mg/m², IV, D1, Q3W; Capecitabine: 1000 mg/m², po, BID, D1-D14, Q3W
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, BJ-Beijing, China
Countries
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Central Contacts
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Facility Contacts
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shen lin shen, PhD
Role: primary
Other Identifiers
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RC48-C039
Identifier Type: -
Identifier Source: org_study_id
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