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A Single-Arm Study of QL1706 Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric/GEJ Adenocarcinoma
Sponsor: The First Affiliated Hospital of Zhengzhou University
Summary
This is an open-label, prospective, interventional study designed to enroll 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma, aiming to evaluate and observe the efficacy and safety of QL1706 in combination with DOS for the treatment of locally advanced gastric or gastroesophageal junction adenocarcinoma. Enrolled patients will receive iparomlimab and tuvonralimab in combination with the DOS regimen (docetaxel + oxaliplatin + S-1) administered in 21-day treatment cycles. Subjects who complete 3-4 cycles of treatment and are deemed suitable for surgery will undergo gastrectomy, with the specific interval between neoadjuvant therapy and surgery determined by the investigator based on actual clinical circumstances. Following surgery, clinicians will administer postoperative treatment according to the postoperative pathological assessment results and the clinical practice treatment principles of the study center. The primary endpoint is the pathological complete response rate assessed by postoperative pathological evaluation.
Official title: A Single-Arm, Prospective, Open-Label Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-11
Completion Date
2029-12
Last Updated
2026-09-18
Healthy Volunteers
No
Interventions
Iparomlimab and Tuvonralimab Injection (QL1706)
5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
Docetaxel
40 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
Oxaliplatin
100 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.
Tegafur-Gimeracil-Oteracil
40 mg/m², oral, twice daily (BID), D1-14, every 21 days per cycle, for 3-4 cycles.
Gastrectomy
Subjects who complete 3-4 cycles of neoadjuvant therapy and are deemed suitable for surgery will undergo gastrectomy. The specific interval between neoadjuvant therapy and surgery will be determined by the investigator based on actual clinical circumstances.
Locations (1)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China