Actively Recruiting
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.
Led by RemeGen Co., Ltd. · Updated on 2026-01-21
555
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily consent to participate and sign informed consent
- Expected survival longer than 12 weeks
- ECOG Performance Status of 0 or 1
- Histologically confirmed unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- No prior systemic therapy for advanced disease or recurrence at least 6 months after prior neoadjuvant/adjuvant therapy
- HER2-high expression
- At least one measurable lesion per RECIST v1.1
- Adequate organ function
- Women of childbearing potential with a negative pregnancy test within 7 days prior to treatment and agree to avoid breastfeeding or donating eggs until 6 months after last treatment
- Men agree not to donate sperm until 6 months after last treatment
- Able to understand study and willing to comply with procedures
You will not qualify if you...
- Presence of central nervous system metastasis or carcinomatous meningitis
- Peripheral neuropathy greater than Grade 1
- Tumors prone to bleeding
- Severe gastrointestinal dysfunction affecting drug intake or absorption
- Bone metastases with risk of paraplegia
- Past or current interstitial lung disease or severely impaired lung function
- Other cancers within 5 years, except those expected to be cured
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, BJ-Beijing, China, 100021
Actively Recruiting
Research Team
H
Hongfang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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