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New treatment option for Cancer
Official title SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors
ClinicalTrials.gov ID: NCT06936748
What this study is testing
What is Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab?
Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors. Secondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years, male or female.
- Histologically confirmed malignant tumor in the past.
- Disease recurrence after treatment, including local regional relapsed and distant metastasis.
- At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.
- ECOG: 0-2 points.
You likely can't join if
- History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
- Any of the following conditions within 6 months prior to screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral...
- History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
- Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can...
- Controlled Type 1 diabetes
- Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
See the full eligibility criteria
- Age 18-75 years, male or female.
- Histologically confirmed malignant tumor in the past.
- Disease recurrence after treatment, including local regional relapsed and distant metastasis.
- At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.
- ECOG: 0-2 points.
- Expected survival ≥3 months.
- Washout period of previous anti-tumor treatment \>4 weeks.
- The patient agrees and signs the informed consent form.
- 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...
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- Platelets ≥90×10\^9/L;
- Hemoglobin ≥8g/dL;
- Serum albumin ≥2.8g/dL;
- 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;
- Serum creatinine ≤1.5×ULN or creatinine clearance rate greater than 60 mL/min;
- 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...
- Negative pregnancy test for female people (for female patients of childbearing potential);
- The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up;
- The investigator believes that the patient may benefit.
- History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
- 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...
- History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
- 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:
- Controlled Type 1 diabetes
- Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
- Skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia)
- Any other condition not expected to recur without external triggering factors
- Lack of civil capacity or limited civil capacity.
- 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.
- Patients with an expected survival of less than 3 months.
- Patients with significantly diminished cardiac, hepatic, pulmonary, renal, and bone marrow function.
- Drug abuse or alcohol addiction.
- Tumor lesions invading major blood vessels such as the internal carotid artery and vein and their major branches, posing a high risk of bleeding.
- people 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...
- History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation.
- 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...
- The investigator deems the patient unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.