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NOT YET RECRUITING
NCT07400315
PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-03-01

Completion Date

2029-03-31

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

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: