HER2 NegativePhase 2SEARCHNCT06932068
Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706), Oxallplation and Capectitabine Tablets in people with HER2 Negative and Low PD-L1 Expressing, run by Qilu Hospital of Shandong University at 29 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Negative, Low PD-L1 Expressing, Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706), Oxallplation and Capectitabine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 29 sitesChina
- Study dates
- 26 Mar 2025to 31 Oct 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, gender is not limited;
- Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
- HER2-negative by immunohistochemistry (IHC);
- low PD-L1 expression status (CPS < 5);
- Has at least 1 measurable lesion as determined by RECIST 1.1;
- 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;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Adequate organ function;
- The life expectancy is at least 3 months;
- Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.
Who cannot join
- Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
- Cardiovascular and cerebrovascular events that are not well controlled;
- 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;
- 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.);
- 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;
- 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;
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- Brain metastasis or leptomeningeal metastasis;
- 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;
- 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);
- Any major surgery was performed ≤ 28 days before the first trial drug administration;
- History of allogeneic stem cell transplantation or organ transplantation;
- 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;
- Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
- 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;
- Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;
- Others conditions do not meet the inclusion according to the judgment of the investigator.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Song Li, MD, PHD contact
29 sites in 1 country
China29 sites, 29 recruiting
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong
Feng Wang
- Recruiting
Dezhou People's Hospital
Dezhou, Shandong
Tao Li
- Recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong
Tingting Zhang, MD, 18766757077, ztt850426@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Lian Liu, MD, PHD, 0531-82169851, tounao@126.com
Song Li, MD, PHD, 0531-82169851, songli@sdu.edu.cn
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250012
Lei Cong, MD, 15168889208, wdconglei@163.com
Lei Cong, MD
- Recruiting
Shandong Provincial Third Hospital
Jinan, Shandong, 250012
Kainan Li, Doctor, 15053125301, lkn_bean@163.com
- Recruiting
Jinan Central Hospital
Jinan, Shandong
Meili Sun
- Recruiting
Jinan Third People's Hospital
Jinan, Shandong
Zupeng Luan
- Recruiting
Shandong Qianfoshan Hospital
Jinan, Shandong
Jing Liang
- Recruiting
Affiliated Hospital of Jining Medical College
Jining, Shandong
Junye Wang, MD
- Recruiting
Jining First People's Hospital
Jining
Jie Li
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong
Baozhong Wang
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong
Zhen Li
- Recruiting
Linyi People's Hospital
Linyi, Shandong
Jinling Zhang
- Recruiting
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, 250063
Fangli Cao, MD, 18561811170, qdsunying@foxmail.com
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
xiaomei Xu
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Lu Yue
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Ziming Liu
- Recruiting
Taian City Central Hospital
Tai’an, Shandong
Li Meng, MD
- Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong
Haiyan Liu, MD, 13001770627, Fylhy1998@163.com
- Recruiting
Tengzhou Central People's Hospital
Tengzhou, Shandong, 277599
Lin Li, MD, 13863260929, lilingtz@163.com
- Recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong
Zhonghai Du
- Recruiting
Weihai Central Hospital
Weihai, Shandong
Ming Wang
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Aina Liu, nana4312@sina.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Ping Sun
- Recruiting
Yantaishan Hospital
Yantai, Shandong
Dongmei Zhou, MD, 13953590373, zhoudongmei68@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yongxu Jia, MD, 15237128281, jiayongxu111@126.com
Yanru Qin, MD, yanruqin@163.com
- Recruiting
Zibo Central Hospital
Zibo, Shandong
Yi Zhai, MD, 18678186991, zhai-yi@21cn.com
- Recruiting
Zibo First People's Hospital
Zibo, Shandong
Fei Ding
About this study
Official title: Safety and Efficacy of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for the Treatment of HER2-Negative, Low PD-L1 Expressing, Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Single-Arm Trial
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
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), Oxallplation, Capectitabine Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Drug
5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
OxallplationDrug
130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
Capectitabine TabletsDrug
1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + XELOX chemotherapy | Experimental | Iparomlimab and Tuvonralimab+XELOX Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: Oxallplation; Drug: Capectitabine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
Measured: 12 months after the last subject participating in
Secondary outcomes (5)
overall survival (OS)
The time from the starting date of study drug to the date of death due to any cause.
Measured: 12 months after the last subject participating in
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
Measured: 6 months after the last subject participating in
duration of response (DOR)
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measured: 12 months after the last subject participating in
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Measured: 12 months after the last subject participating in
Safety (adverse event)
The rates of adverse events.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start26 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 NegativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lian Liu, MD, PHD, Qilu Hospital of Shandong University
- Investigators
- Lian Liu, MD, PHD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932068
- Sponsor's protocol ID
- SEARCH
- Acronym
- SEARCH
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided