SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors

Launched by SECOND AFFILIATED HOSPITAL OF NANCHANG UNIVERSITY · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with recurrent or hard-to-treat solid tumors, which are types of cancer that have come back after previous treatment. The trial combines a type of radiation therapy called SFRT (Stereotactic Fractionated Radiation Therapy) with another type of radiation and an immunotherapy drug called Ipilimumab Tuvorilimab. The main goal is to see how safe this combination is for patients, while also measuring how effective it is in controlling the cancer.

To participate in this trial, you need to be between 18 and 75 years old and have a confirmed history of cancer that has returned. You should have at least one measurable tumor that is too large or complicated to be treated with standard surgery or other methods. Participants will be closely monitored for any side effects and will need to agree to follow the study's guidelines. This trial is not yet recruiting patients, but it aims to help researchers understand better ways to treat difficult cancers and identify specific markers in the body that could predict treatment success.

Gender

ALL

Eligibility criteria

• 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.