Actively Recruiting
Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
Led by Qilu Hospital of Shandong University · Updated on 2026-05-07
77
Participants Needed
29
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Pathologically confirmed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that cannot be surgically removed
- HER2-negative as determined by immunohistochemistry
- Low PD-L1 expression (combined positive score less than 5)
- At least one measurable tumor lesion by RECIST 1.1 criteria
- No prior systemic treatment or disease progression/relapse more than 6 months after prior neoadjuvant/adjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Expected life expectancy of at least 3 months
- Willingness to participate and provide signed informed consent with good compliance and ability to follow up
You will not qualify if you...
- Allergy to any study drug or its components, history of serious allergy, or contraindications to the study drugs
- Uncontrolled cardiovascular or cerebrovascular conditions
- Use of systemic Chinese patent medicine or immunomodulatory drugs within 2 weeks before first treatment (except local use for ascites)
- History of interstitial lung disease, pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases such as diabetes or hypertension
- Active immune deficiency, autoimmune diseases, HIV positive, history of organ transplantation
- Severe or active infections requiring systemic treatment, including tuberculosis without completed treatment
- Brain or leptomeningeal metastases
- Clinically significant pleural, pericardial effusion, or ascites requiring frequent drainage within 2 weeks before treatment
- Presence of a second primary malignant tumor or other cancers within past 5 years (except treated skin basal cell or cervical carcinoma in situ)
- Major surgery within 28 days before first treatment
- History of allogeneic stem cell or organ transplantation
- Current gastrointestinal diseases causing bleeding or perforation risk, or previous intestinal perforation/fistula not resolved
- Live vaccine within 4 weeks before first treatment (except seasonal influenza nasal vaccine)
- Other serious diseases, mental health conditions, lab abnormalities, or social factors affecting safety or data collection
- Participation in other therapeutic clinical trials or use of research devices within 4 weeks before first treatment
- Other conditions judged by investigators as incompatible with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
2
Binzhou Medical University Hospital
Binzhou, Shandong, China
Actively Recruiting
3
Dezhou People's Hospital
Dezhou, Shandong, China
Actively Recruiting
4
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Actively Recruiting
5
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
6
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250012
Actively Recruiting
7
Shandong Provincial Third Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
8
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
9
Jinan Third People's Hospital
Jinan, Shandong, China
Actively Recruiting
10
Shandong Qianfoshan Hospital
Jinan, Shandong, China
Actively Recruiting
11
Affiliated Hospital of Jining Medical College
Jining, Shandong, China
Actively Recruiting
12
Liaocheng People's Hospital
Liaocheng, Shandong, China
Actively Recruiting
13
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
14
Linyi People's Hospital
Linyi, Shandong, China
Actively Recruiting
15
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, China, 250063
Actively Recruiting
16
Qingdao Municipal Hospital
Qingdao, Shandong, China
Actively Recruiting
17
Qingdao Municipal Hospital
Qingdao, Shandong, China
Actively Recruiting
18
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
19
Taian City Central Hospital
Tai’an, Shandong, China
Actively Recruiting
20
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, China
Actively Recruiting
21
Tengzhou Central People's Hospital
Tengzhou, Shandong, China, 277599
Actively Recruiting
22
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, China
Actively Recruiting
23
Weihai Central Hospital
Weihai, Shandong, China
Actively Recruiting
24
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Actively Recruiting
25
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Actively Recruiting
26
Yantaishan Hospital
Yantai, Shandong, China
Actively Recruiting
27
Zibo Central Hospital
Zibo, Shandong, China
Actively Recruiting
28
Zibo First People's Hospital
Zibo, Shandong, China
Actively Recruiting
29
Jining First People's Hospital
Jining, China
Actively Recruiting
Research Team
L
Lian Liu, MD, PHD
CONTACT
S
Song Li, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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