Actively Recruiting
Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2024-07-05
28
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
R
RemeGen Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a prospective, open label, phase II clinical study intended to include patients with locally advanced gastric adenocarcinoma who have not undergone any treatment and are eligible for surgery. The study aims to evaluate the efficacy and safety of the short course sequential radiotherapy regimen of Disitamab Vedotin combined with S-1 and Sintilimab in neoadjuvant therapy for HER2 expressing locally advanced gastric cancer.
CONDITIONS
Official Title
Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and able to sign informed consent with good compliance
- Age between 18 and 75 years at consent signing, any gender
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma with local progression (cT3-4N+M0) suitable for radical surgery
- No prior systemic treatment for current disease, including radiotherapy, chemotherapy, or immunotherapy
- Confirmed HER2 expression by IHC (1+, 2+, or 3+)
- ECOG performance status of 0 or 1
- Expected survival time of at least 6 months
- Adequate function of main organs
- Use effective contraception during the study and for 120 days after; negative pregnancy test within 7 days before enrollment; not breastfeeding
You will not qualify if you...
- Malignant diseases other than gastric cancer diagnosed within 5 years before starting treatment (except treated basal or squamous cell carcinoma of the skin and carcinoma in situ)
- Tumor prone to bleeding or recent history of bleeding or blood transfusion within 4 weeks prior to treatment
- Unable to take oral medication
- Participation in other interventional clinical studies or use of investigational drugs/instruments within 4 weeks before treatment
- Previous treatment with anti-HER2, anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor-targeting drugs
- Use of systemic traditional Chinese medicine or immunomodulatory drugs within 2 weeks before treatment
- Active autoimmune disease requiring systemic treatment within past 2 years
- Current systemic glucocorticoid or immunosuppressive therapy within 7 days before first treatment (physiological doses allowed)
- History of allogeneic organ or stem cell transplantation (except corneal transplant)
- Known allergy to study drugs
- Peripheral neuropathy grade 2 or higher
- Known HIV infection
- Active hepatitis B or C infection
- Receipt of live vaccine within 30 days before first treatment (inactivated vaccines allowed except live influenza nasal spray)
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases
- Any medical condition or lab abnormality that may interfere with study participation or results as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhang Tao
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
T
Tao Zhang, MD
CONTACT
Z
Zhenyu Lin, MD
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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