NCT07400315

First-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Dual Immunotherapy Combined With Chemotherapy

A Prospective, Single-arm, Multicenter, Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Modified FLOT Regimen (TFOX) as First-line Treatment for HER2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, multicenter, Phase II clinical study of Apatolimab Tovolimab (QL1706) in combination with modified FLOT regimen (TFOX) as first-line treatment for HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma

Conditions

• Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection in combination with TFOX	Participants enrolled will receive QL1706 (5 mg/kg, Q3W, d1) + docetaxel (50 mg/m², Q3W, d1) + oxaliplatin (100 mg/m², Q3W, d1) + leucovorin (LV) (400 mg/m², Q3W, d1) + 5-fluorouracil (5-FU) (2400 mg/m², Q3W, continuous infusion for 46 hours). The treatment cycle is 21 days, continuing until disease progression, intolerable toxicity, the investigator determines that the participant no longer benefits, the participant withdraws informed consent, QL1706 treatment is completed for 2 years, or other reasons specified in the protocol.Other Name:

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-31
• Completion: 2029-03-31
• First posted: 2026-02-10
• Last updated: 2026-02-10