Actively Recruiting
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
Led by Chinese PLA General Hospital · Updated on 2024-01-08
42
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.
CONDITIONS
Official Title
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily consent to participate in the study
- Male or female aged 18 years or older
- Diagnosed with gastric cancer, gastroesophageal junction carcinoma, or esophageal adenocarcinoma confirmed by pathology or cytology, with locally advanced or metastatic disease not suitable for surgery
- No prior systemic therapy, or disease recurrence or progression at least 6 months after neoadjuvant/adjuvant chemotherapy
- HER2 IHC 2+ and FISH negative
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 3 months
- Women of childbearing potential have a negative pregnancy test within 7 days before enrollment and agree to use contraception during the study and for 12 weeks after last study drug administration; men agree to use contraception during the study and for 12 weeks after last study drug administration
- Able and willing to comply with follow-up requirements for treatment outcomes and adverse reactions
You will not qualify if you...
- History of other malignant tumors within 5 years before first use of study drug, except effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or breast cancer
- Known allergy to RC48-ADC
- Hepatitis B virus DNA > 500 IU/mL, hepatitis C virus RNA > 103 copies/mL, or positive for HBsAg and anti-HCV antibody
- History of HIV infection
- Received anti-cancer drugs or biological treatments within 4 weeks before trial treatment
- Assessed by investigator as unable or unwilling to comply with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Friendship Hospital
Beijing, China
Actively Recruiting
2
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
3
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
R
Ru Jia
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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