New combo therapy takes on bulky tumors
NCT ID NCT06936748
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a new approach for people with large, relapsed solid tumors that have not responded to standard treatments. It combines a special type of radiation (spatially fractionated radiation therapy) with two immunotherapy drugs (iparomlimab and tuvonralimab). The goal is to see if this combination is safe and can shrink tumors or control the disease. The study will enroll 30 participants and will also look for biomarkers that might predict who benefits most.
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 (immunotherapy drugs) plus spatially fractionated radiation therapy
- What this could lead to
- If it works, this could offer a new treatment option for people with large, treatment-resistant tumors, potentially shrinking them and slowing disease progression.
- What could go wrong
- This is an early phase 2 trial with only 30 participants, so results may not apply to everyone. The combination of radiation and immunotherapy can cause significant side effects, and it's not yet known if it will be more effective 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
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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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 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. Age 18-75 years, male or female. 2. Histologically confirmed malignant tumor in the past. 3. Disease recurrence after treatment, including local regional relapsed and distant metastasis. 4. At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments. 5. ECOG: 0-2 points. 6. Expected survival ≥3 months. 7. Washout period of previous anti-tumor treatment \>4 weeks. 8. The patient agrees and signs the informed consent form. 9. The function of vital organs meets the following requirements (no use of any blood components, cell growth factors, leukocyte boosters, platelet boosters, or anemia correction drugs within 14 days prior to the first use of the study drug): 1. Absolute neutrophil count (ANC) ≥1.5×10\^9/L; 2. Platelets ≥90×10\^9/L; 3. Hemoglobin ≥8g/dL; 4. Serum albumin ≥2.8g/dL; 5. Total bilirubin ≤1.5×ULN, ALT, AST, and/or AKP ≤2.5×ULN; if liver metastasis is present, ALT and/or AST ≤5×ULN; if liver or bone metastasis is present, AKP ≤5×ULN; 6. Serum creatinine ≤1.5×ULN or creatinine clearance rate greater than 60 mL/min; 7. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients on stable doses of anticoagulation therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range can be screened). 10. Negative pregnancy test for female subjects (for female patients of childbearing potential); 11. The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up; 12. The investigator believes that the patient may benefit. Exclusion Criteria: 1. History of severe immediate hypersensitivity reaction to any of the drugs used in this study. 2. Any of the following conditions within 6 months prior to screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. Patients known to have coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \<50% must be on an optimized stable medical regimen as determined by the treating physician; consultation with a cardiologist may be appropriate if necessary. 3. History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug. 4. Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can proceed to further screening: 1. Controlled Type 1 diabetes 2. Hypothyroidism (if it can be controlled with hormone replacement therapy alone) 3. Skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia) 4. Any other condition not expected to recur without external triggering factors 5. Lack of civil capacity or limited civil capacity. 6. Physical or mental conditions that impair the patient's ability to fully or adequately understand the potential complications of this study, as judged by the investigator. 7. Patients with an expected survival of less than 3 months. 8. Patients with significantly diminished cardiac, hepatic, pulmonary, renal, and bone marrow function. 9. Drug abuse or alcohol addiction. 10. Tumor lesions invading major blood vessels such as the internal carotid artery and vein and their major branches, posing a high risk of bleeding. 11. Subjects requiring systemic treatment with corticosteroids (more than 10mg/day prednisone equivalent dose) or other immunosuppressive agents within 2 weeks prior to the first use of the investigational drug, except for the use of corticosteroids for local esophageal inflammation and prevention of allergies and nausea/vomiting. Special cases need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacements at doses \>10mg/day prednisone equivalent are allowed. 12. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation. 13. Pregnant or breastfeeding female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception for at least 1 year after the end of the treatment protocol throughout the study period. 14. The investigator deems the patient unsuitable for inclusion.
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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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The Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, 330006, China
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