Immunotherapy duo aims to shrink stomach tumors before surgery
NCT ID NCT06829797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether adding an immunotherapy drug (QL1706) to standard chemotherapy before and after surgery can improve outcomes for people with locally advanced stomach or gastroesophageal junction cancer. About 96 participants will be randomly assigned to receive either the combination or chemotherapy alone. The main goal is to see if the combination leads to a higher rate of complete tumor disappearance (pathological complete response) at the time of surgery.
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 SOX chemotherapy
- What this could lead to
- If successful, this combination could become a new standard neoadjuvant treatment, potentially improving the chance of complete tumor removal and long-term control for locally advanced gastric cancer.
- What could go wrong
- This is an early Phase 2 trial with only 96 participants, so results may not be definitive. Adding immunotherapy to chemotherapy can increase side effects, and the benefit over chemotherapy alone is not yet proven.
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 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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: * Voluntary participation in the study and signing of informed consent; * Age ≥18 years and ≤75 years; * Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; * Clinical staging of T3N+ or T4a any N, M0 (according to AJCC 8th edition staging), with potential radical resection confirmed by CT or MRI; * Have not received any anti-tumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy); * Planned to undergo surgery after completion of neoadjuvant therapy; * Be able to swallow pills normally; * ECOG-PS score 0-1; * Expected survival ≥ 12 months; * Normal major organ function. Exclusion Criteria: * Known HER2 positivity; * Known peritoneal metastases or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); * Presence of unresectable factors including unresectable tumors, contraindications to surgery and refusal of surgery; * The presence of a pre-existing or concurrent malignancy, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast * History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or concomitant intestinal obstruction as indicated by imaging or clinical signs; * Patients with abnormal coagulation (International Normalized Ratio (INR) \>2.0 or Prothrombin Time (PT) \>16s), a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed); * Clinically significant bleeding symptoms or significant bleeding tendency such as gastrointestinal bleeding, gastric ulcer bleeding, and vasculitis within 3 months prior to randomization into groups. Patients with positive fecal occult blood at baseline may be retested, and if the retest remains positive, gastroscopy will be required (except for patients who have had a gastroscopy within 3 months prior to enrollment to rule out this condition); * Arterial/venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to randomization to group; * A known hereditary or acquired predisposition to bleeding and thrombosis (e.g., hemophilia, coagulation disorders, and thrombocytopenia); * The presence of active ulcers, unhealed wounds or fractures * Urinalysis showing urinary protein ≥++, confirmed by 24-hour urine protein quantification \>1.0 g; * Active infections requiring antimicrobial therapy (e.g., antibacterial, antiviral, and antifungal medications); * Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/mL; Hepatitis C reference: HCV antibody positive and HCV viral copy number \> upper limit of normal (ULN)); * Congenital or acquired immunodeficiency (e.g., HIV-infected patients); * Planned or previous organ or allogeneic bone marrow transplant; * Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, opportunistic pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonia, and idiopathic pneumonitis, or active pneumonitis or severe pulmonary impairment as demonstrated by CT at screening; Active tuberculosis; * Any active autoimmune disease or history of autoimmune disease with potential for relapse; * Treatment with immunosuppressive drugs or systemic corticosteroids (\>10 mg/day of prednisone or equivalent) within 7 days prior to randomization to group; * Use of a strong CYP3A4 inducer within 2 weeks prior to randomization subgroup or use of a strong CYP3A4 inhibitor within 1 week prior to randomization subgroup * Oral or intravenous administration of therapeutic antibiotics within 4 weeks prior to randomization to subgroups, except for prophylactic antibiotics administered intravenously for no more than 48 hours * Known allergy to any study drug or excipient; * Participation in a clinical study of another drug within 4 weeks prior to randomization to group; * Being a lactating female.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Shandong Provincial Hospital
RECRUITINGJinan, Shandong, 250021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Arterial chemo combo shows promise in stomach cancer trial
- New drug cocktail aims to fight Hard-to-Treat stomach cancers
- New triple therapy aims to shrink stomach tumors before surgery
- Could blood pressure pills boost stomach cancer treatment?