A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 3

Not yet recruiting

• Conditions: Gastric Carcinoma
• Interventions: Biological: Tislelizumab+Oxaliplatin+Capecitabine; Biological: Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine

• Registration Number: NCT06944496
• Lead Sponsor: RemeGen Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Study Start: 2025-05-15
• Primary Completion: 2028-05-15
• Study Completion: 2030-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 616

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, 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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with CAPOX	Tislelizumab+Oxaliplatin+Capecitabine	-
Disitamab Vedotin Combined with Tislelizumab and CAPOX	Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	24 months

Secondary Outcome Measures

Name	Time	Method
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
Adverse Events	24 months

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, BJ-Beijing, China