Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
NCT06932068 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77
Last updated 2026-05-07
Summary
This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
Conditions
- HER2 Negative
- Low PD-L1 Expressing
- Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
Interventions
- DRUG
-
Iparomlimab and Tuvonralimab (QL1706)
5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
- DRUG
-
Oxallplation
130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
- DRUG
-
Capectitabine Tablets
1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.
Sponsors & Collaborators
-
Qilu Hospital of Shandong University
lead OTHER
Principal Investigators
-
Lian Liu, MD, PHD · Qilu Hospital of Shandong University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-26
- Primary Completion
- 2026-10-31
- Completion
- 2027-10-31
Countries
- China
Study Locations
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