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RECRUITING
NCT07776639
PHASE2

Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

Sponsor: Yongxu Jia

View on ClinicalTrials.gov

Summary

This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.

Official title: A Single-Arm, Prospective, Open-Label Clinical Study of Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-05-10

Completion Date

2028-11

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

Iparomlimab and Tuvonralimab Injection (QL1706)

5 mg/kg intravenous infusion on Day 1 every 3 weeks.

DRUG

S-1

40 mg/m² orally twice daily on Day 1-14 every 3 weeks.

DRUG

Oxaliplatin

100 mg/m² intravenous infusion on Day 1 every 3 weeks.

DRUG

Docetaxel

40 mg/m² intravenous infusion on Day 1 every 3 weeks.

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China