New Immunotherapy-Chemo cocktail targets stomach cancer
NCT ID NCT07400315
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase II trial tests a new combination of two immunotherapy drugs (iparomlimab and tuvonralimab, together called QL1706) plus chemotherapy for people with advanced HER2-negative stomach or gastroesophageal junction cancer. The study will enroll 64 participants who have not had prior treatment for their advanced disease. The goal is to see if this combination can slow cancer growth and improve survival, while monitoring side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QL1706 (iparomlimab and tuvonralimab) plus chemotherapy (docetaxel, oxaliplatin, leucovorin, 5-fluorouracil)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option that delays cancer progression and improves survival for people with advanced gastric cancer.
- What could go wrong
- This is an early Phase II trial with only 64 participants and no control group, so results may not be definitive. The combination also carries risks of serious side effects from both immunotherapy and chemotherapy.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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\. The participant voluntarily agrees to participate in this study, signs the informed consent form, and strictly adheres to the requirements of the study protocol. * 2\. Age ≥18 years and ≤75 years at enrollment, regardless of gender. * 3\. Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma, with inclusion criteria specifying HER2- status (HER2+ status defined as IHC3+ or IHC2+ and FISH+). * 4\. No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma; previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 12 months prior to the diagnosis of unresectable or metastatic disease. * 5\. At least one measurable tumor lesion according to RECIST 1.1 criteria. * 6\. ECOG PS of 0 or 1. * 7\. Life expectancy ≥3 months. * 8\. Fully recovered from any toxicities related to prior treatments prior to enrollment in the study. * 9\. BMI \>18. * 10\. Adequate function of major organs * 11\. Fertile subjects must use appropriate contraception during the study and for 120 days after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding. Exclusion Criteria: * 1\. Any unstable systemic disease: including active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (New York Heart Association \[NYHA\] ≥Class II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, or hepatic, renal, or metabolic diseases. * 2\. Symptomatic brain and/or leptomeningeal metastases. * 3\. Known deficiency of dihydropyrimidine dehydrogenase (DPD). * 4\. QT/QTc interval \>450 ms for males, \>470 ms for females. * 5\. History of other malignancies within 5 years prior to enrollment, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin. * 6\. History of organ transplantation or autologous/allogeneic stem cell transplantation. * 7\. Currently receiving systemic immunotherapy or hormone therapy other than physiologic replacement therapy. * 8\. Other concurrent anti-tumor treatments. * 9\. Known hypersensitivity or allergic reaction to any component of the study treatment. * 10\. Previous exposure to docetaxel or oxaliplatin (except for adjuvant chemotherapy). * 11\. Previous exposure to immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or any immunotherapy targeting tumor immune mechanisms. * 12\. Participants with severe bone marrow failure. * 13\. Any disease, metabolic disorder, or physical examination or laboratory findings that suggest contraindications to the study drug or high-risk factors for treatment complications. * 14\. Known or self-reported human immunodeficiency virus (HIV) infection. * 15\. Participants who are HBV or HCV positive. * 16\. Pregnant or breastfeeding. * 17\. Received a live vaccine within 4 weeks prior to the first dose, or plans to receive a live vaccine during the study. * 18\. Participated in any investigational drug treatment or used any investigational device within 4 weeks prior to the first dose. * 19\. Any condition that the investigator believes may pose a risk to the participant receiving the study drug, or may interfere with the evaluation of the study drug, the safety of the participant, or the interpretation of the study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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