Prospective, Phase II Clinical Study of 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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 1\. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance; 2. Age range from 18 to 75 years old (when signing the informed consent form), regardless of gender; 3. Gastric cancer or gastroesophageal junction adenocarcinoma confirmed by histology and/or cytology, diagnosed with local progression according to AJCC 8th edition standards, cT3-4N+M0 diagnosed with cTNM based on endoscopic ultrasound or enhanced CT/MRI scanning (combined with diagnostic laparoscopic exploration if necessary), and agreeing to undergo radical surgical treatment. The researcher evaluates the lesion as resectable; 4. Have not received systematic treatment for the current disease in the past, including anti-tumor radiotherapy, chemotherapy, immunotherapy, etc; 5. IHC results confirm HER2 expression (defined as IHC1+, 2+, 3+); 6. ECOG score 0-1 points; 7. Expected survival time ≥ 6 months; 8. The main organs are functioning well; 9. Fertility subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study. They must have a negative serum pregnancy test within 7 days before enrollment and must be non lactating subjects.

Locations
Other Locations
China
Zhang Tao
RECRUITING
Wuhan
Contact Information
Primary
Tao Zhang, MD
1277577866@qq.com
02785871982
Backup
Zhenyu Lin, MD
tojilin@gmail.com
15827130393
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 28
Treatments
Experimental: Short term radiotherapy with continuous use of Disitamab Vedotin, Sintilimab, and S-1
Short range radiotherapy, PCTV (Clinical Plan Target Area) DT 25Gy/5F, once daily for a total of 5 days, continuous irradiation, and IMRT (Intensity Modulated Radiotherapy) technology; After a week of rest, radiotherapy and chemotherapy combined with immunotherapy will be performed~* Disitamab Vedotin: 2.5 mg/kg, intravenous infusion, d1,Q3W;~* Sintilimab: 200mg, iv;~* S-1: 40 mg/dose, oral, bid,d1-14;Q3W
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov