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Tests treatment safety and results for Advanced Solid Tumor
Official title Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
ClinicalTrials.gov ID: NCT06173219
What this study is testing
What is Radiotherapy combined with immunotherapy?
Radiotherapy combined with immunotherapy is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced solid tumor.
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
- The goal of this clinical trial is to find a new radioimmunotherapy regimen for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The main questions it aims to answer is: the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function.
- 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
- advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record;
- disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due...
- patients with disease progression or drug resistance after previous immunotherapy are allowed to be included; a history of radiotherapy in the LDRT...
- at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured;
- no contraindications to radiotherapy;
You likely can't join if
- no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met;
- permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions;
- serious cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, serious and uncontrolled systemic infections or other...
- any active immune system disease or related history;
- systemic immunosuppressive drugs are expected to be used during the study;
- a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment...
See the full eligibility criteria
- advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record;
- disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness;
- patients with disease progression or drug resistance after previous immunotherapy are allowed to be included; a history of radiotherapy in the LDRT area or other sites is allowed to be included, provided that there are...
- at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured;
- no contraindications to radiotherapy;
- Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy \>3 months;
- important organ function is acceptable, defined as: white blood cells ≥3.0×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥90g/L, glutamic pyruvic transaminase and glutamic oxalacetic transaminase ≤2.5 times the upper limit...
- voluntary participation and sign the informed consent.
- no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met;
- permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions;
- serious cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, serious and uncontrolled systemic infections or other contraindications, or any contraindications to radiotherapy, and some...
- any active immune system disease or related history;
- systemic immunosuppressive drugs are expected to be used during the study;
- a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance;
- other important medical or physiological conditions (such as pregnancy or breastfeeding status);
- patients who are known to be allergic to the drugs used in this study;
- patients refuse or are unable to sign the informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.