Actively Recruiting
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
Led by Zhejiang Cancer Hospital · Updated on 2024-08-27
35
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors
CONDITIONS
Official Title
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age between 18 and 75 years (including 18, excluding 75), any gender
- Pathologically confirmed adenocarcinoma of the gastric or gastroesophageal junction
- HER2 positive tumor defined as IHC 2+/FISH+ (HER2: CEP17 ratio 6 2.0) or IHC 3+
- Recurrent or metastatic disease not suitable for surgery with at least one measurable lesion
- Estimated survival time of at least 12 weeks
- ECOG performance status score of 0 or 1
- At least one prior systemic therapy has failed
- Adequate bone marrow, liver, and kidney function as specified
- Women of childbearing potential and their partners agree to use effective contraception during the study and for 7 months after
You will not qualify if you...
- Allergy to study drugs or their components
- Left ventricular ejection fraction less than 50%
- Prior treatment with anti-HER2 antibody-drug conjugates
- Systemic immunotherapy, biologic therapy, or participation in other clinical trials within 2 weeks
- Surgery within 3 weeks before starting study treatment without full recovery
- Uncontrolled central nervous system metastases or epilepsy requiring medication
- Serious uncontrolled systemic diseases like diabetes
- Other cancers within 5 years except certain skin or cervical cancers
- Symptomatic coronary heart disease, cardiomyopathy, congestive heart failure (NYHA III-IV), uncontrolled hypertension, symptomatic heart valve disease, or high-risk arrhythmias
- Long-term or high-dose corticosteroid treatment (short-term steroids allowed for vomiting or appetite)
- Lack of legal capacity or other medical/ethical reasons preventing participation
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Uncontrolled pleural or peritoneal effusion
- Persistent severe infection, non-healing wounds, ulcers, fractures, or history of organ transplant
- Unresolved toxicities from prior treatments except hair loss, anemia, or hypothyroidism
- Assessed by investigators as unsuitable for participation
- Participation in another clinical trial simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
J
Jieer Ying, M.D.
CONTACT
J
Jieer Ying, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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