Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug combo aims to shrink stomach tumors before surgery

NCT ID NCT07595523

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a new immunotherapy drug called iparomlimab tolvorlimab (QL1706) in 30 people with a specific type of locally advanced stomach cancer (MSI-H/dMMR). The drug is given before and after surgery to see if it can eliminate the tumor. The main goal is to see how many patients have no cancer cells left in their removed tissue.

What this could mean

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

Active substance
iparomlimab tolvorlimab (QL1706)
What this could lead to
If successful, this could provide a new treatment option for patients with a specific type of gastric cancer that doesn't respond well to standard chemotherapy.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to all patients. The drug can cause immune-related side effects, and it's not yet proven to be better than existing treatments.

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 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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. The subject voluntarily enrolls in this study, is able to provide signed informed consent, and has good compliance. 2. Aged 18 to 75 years (at the time of signing informed consent), male or female. 3. Histologically confirmed gastric adenocarcinoma, clinically staged as Stage II-III (locally advanced) per AJCC 8th edition based on endoscopic ultrasound or contrast-enhanced CT/MRI scan. The subject agrees to undergo radical resection, and the lesion is assessed as resectable by the investigator. No prior systemic therapy for the current disease, including anti-tumor chemotherapy, radiotherapy, or immunotherapy. 4. Tumor biopsy demonstrates dMMR status and concurrently meets the criteria for MSI-H. 5. ECOG performance status score of 0 to 1. 6. Expected survival ≥ 6 months. 7. Adequate major organ function, meeting the following criteria: a) Routine blood test (without blood transfusion or hematopoietic stimulating agents within 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelets (PLT) ≥ 100 × 10⁹/L; b) Blood biochemistry: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; Total Bilirubin (TBIL) ≤ 1.5 × ULN; Serum Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min; Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) ≤ 1.5 × ULN; c) Doppler echocardiography: Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 8. Subjects of reproductive potential must use an effective contraceptive method during the study and for 120 days after study completion. Female subjects must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding. Exclusion Criteria: 1. History of other malignant diseases other than gastric cancer diagnosed within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, radically resected carcinoma in situ, and papillary thyroid carcinoma curable by local treatment). 2. Currently participating in an interventional clinical study, or having received other investigational medicinal products or investigational device therapy within 4 weeks prior to the first dose. 3. Received systemic therapy with Chinese patent medicine with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 2 weeks prior to the first dose. 4. History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy. 5. Receiving systemic corticosteroid therapy (excluding nasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.Note: Physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent) are permitted. 6. History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 7. Known hypersensitivity to any study drug used in this study. 8. Peripheral neuropathy ≥ Grade 2. 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibody). 10. Received live vaccine within 30 days prior to the first dose (Day 1 of Cycle 1). Note: Inactivated seasonal influenza vaccine by injection within 30 days prior to the first dose is permitted; however, live attenuated influenza vaccine administered intranasally is not permitted. 11. Pregnant or lactating female subjects. 12. Presence of any severe or uncontrolled systemic disease, such as: a) Significant and symptomatic uncontrolled abnormalities in cardiac rhythm, conduction, or morphology on resting ECG; b) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA class ≥ 2; c) Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; d) History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease; e) Active pulmonary tuberculosis; f) Active or uncontrolled infection requiring systemic therapy; g) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; h) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; i) Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein \> 1.0 g; j) Mental disorders that prevent cooperation with study treatment. 13. Presence of medical history, abnormal findings, or laboratory abnormalities that may interfere with study results or prevent the subject from completing the study; or any other conditions deemed by the investigator to be inappropriate for enrollment or to pose other potential risks.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Gastric cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.