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New drug cocktail shows promise for Tough-to-Treat stomach cancer

NCT ID NCT06932068

Disease control Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether a combination of two immunotherapy drugs (iparomlimab and tuvonralimab, together called QL1706) plus standard chemotherapy can help people with advanced HER2-negative stomach cancer that has low PD-L1 levels. The study will enroll 77 participants and measure how long the cancer stays under control, overall survival, and tumor shrinkage. It is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iparomlimab and tuvonralimab (QL1706) combined with chemotherapy (oxaliplatin and capecitabine)
What this could lead to
If successful, this could offer a new treatment option for people with advanced gastric cancer who have limited immunotherapy choices.
What could go wrong
This is a small, early-phase trial with no comparison group, so results may not be definitive. Side effects from the drug combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 77 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-negative Low PD-L1 expressing Unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical College

    RECRUITING

    Jining, Shandong, China

  • Binzhou Medical University Hospital

    RECRUITING

    Binzhou, Shandong, China

  • Dezhou People's Hospital

    RECRUITING

    Dezhou, Shandong, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, China

  • Jinan Third People's Hospital

    RECRUITING

    Jinan, Shandong, China

  • Jining First People's Hospital

    RECRUITING

    Jining, China

  • Liaocheng People's Hospital

    RECRUITING

    Liaocheng, Shandong, China

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, Shandong, China

  • Linyi People's Hospital

    RECRUITING

    Linyi, Shandong, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Qilu Hospital of Shandong University(Qingdao)

    RECRUITING

    Qingdao, Shandong, 250063, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shandong Provincial Third Hospital

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shandong Qianfoshan Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shengli Oilfield Central Hospital

    RECRUITING

    Dongying, Shandong, China

  • Taian City Central Hospital

    RECRUITING

    Tai’an, Shandong, China

  • Tengzhou Central People's Hospital

    RECRUITING

    Tengzhou, Shandong, 277599, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Tai’an, Shandong, China

  • Weifang Hospital of Traditional Chinese Medicine

    RECRUITING

    Weifang, Shandong, China

  • Weihai Central Hospital

    RECRUITING

    Weihai, Shandong, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, China

  • Yantaishan Hospital

    RECRUITING

    Yantai, Shandong, China

  • Zibo Central Hospital

    RECRUITING

    Zibo, Shandong, China

  • Zibo First People's Hospital

    RECRUITING

    Zibo, Shandong, China

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