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Clinical Trials in China / NCT06932068
Recruiting Phase 2

Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma

NCT06932068 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Phase 2
Started
2025-03-26
Last updated
2026-05-07

Condition(s) studied

HER2 NegativeLow PD-L1 ExpressingUnresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

Iparomlimab and Tuvonralimab (QL1706) →OxallplationCapectitabine Tablets

Iparomlimab and Tuvonralimab (QL1706): 5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.

Oxallplation: 130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.

Capectitabine Tablets: 1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18-75 years, gender is not limited; 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis; 3. HER2-negative by immunohistochemistry (IHC); 4. low PD-L1 expression status (CPS \< 5); 5. Has at least 1 measurable lesion as determined by RECIST 1.1; 6. No systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 8. Adequate organ function; 9. The life expectancy is at least 3 months; 10. Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up. Exclusion Criteria: 1. Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug; 2. Cardiovascular and cerebrovascular events that are not well controlled; 3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks; 4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.); 5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases; 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment; 7. Brain metastasis or leptomeningeal metastasis; 8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug; 9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. Any major surgery was performed ≤ 28 days before the first trial drug administration; 11. History of allogeneic stem cell transplantation or organ transplantation; 12. Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment; 13. Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine. 14. Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples; 15. Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration; 16. Others conditions do not meet the inclusion according to the judgment of the investigator.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Binzhou Medical University Hospital Binzhou Shandong Recruiting
Dezhou People's Hospital Dezhou Shandong Recruiting
Shengli Oilfield Central Hospital Dongying Shandong Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University Jinan Shandong Recruiting
Shandong Provincial Third Hospital Jinan Shandong Recruiting
Jinan Central Hospital Jinan Shandong Recruiting
Jinan Third People's Hospital Jinan Shandong Recruiting
Shandong Qianfoshan Hospital Jinan Shandong Recruiting
Affiliated Hospital of Jining Medical College Jining Shandong Recruiting
Liaocheng People's Hospital Liaocheng Shandong Recruiting
Linyi Cancer Hospital Linyi Shandong Recruiting
Linyi People's Hospital Linyi Shandong Recruiting
Qilu Hospital of Shandong University(Qingdao) Qingdao Shandong Recruiting
Qingdao Municipal Hospital Qingdao Shandong Recruiting
Qingdao Municipal Hospital Qingdao Shandong Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
Taian City Central Hospital Tai’an Shandong Recruiting
The Second Affiliated Hospital of Shandong First Medical University Tai’an Shandong Recruiting
Tengzhou Central People's Hospital Tengzhou Shandong Recruiting
Weifang Hospital of Traditional Chinese Medicine Weifang Shandong Recruiting
Weihai Central Hospital Weihai Shandong Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Yantaishan Hospital Yantai Shandong Recruiting
Zibo Central Hospital Zibo Shandong Recruiting
Zibo First People's Hospital Zibo Shandong Recruiting
Jining First People's Hospital Jining China Recruiting

More Qilu Hospital of Shandong University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06932068 on ClinicalTrials.gov ↗ ← All trials in China