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NOT YET RECRUITING
NCT07828873
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Iparomlimab and Tuvonralimab Injection (QL1706)

5 mg/kg, intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

DRUG

Docetaxel

40 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

DRUG

Oxaliplatin

100 mg/m², intravenous infusion, administered once every 21 days (D1), for 3-4 cycles.

DRUG

Tegafur-Gimeracil-Oteracil

40 mg/m², oral, twice daily (BID), D1-14, every 21 days per cycle, for 3-4 cycles.

PROCEDURE

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