NCT06173219 Safety and Efficacy of Radiotherapy Combined with Immunotherapy for Advanced Malignant Tumors.
| NCT ID | NCT06173219 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 38 participants in total. It began in 2025-08-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Participants will receive the combination of radiotherapy and immunotherapy.
Eligibility Criteria
Inclusion Criteria: 1. advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record; 2. disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness; 3. 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 no residual toxic effects; 4. at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured; 5. no contraindications to radiotherapy; 6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy \>3 months; 7. 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 of normal value, serum creatinine \< 178μmol/L; 8. voluntary participation and sign the informed consent. Exclusion Criteria: 1. no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met; 2. permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions; 3. 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 comorbidities should be re-evaluated after symptomatic treatment; 4. any active immune system disease or related history; 5. systemic immunosuppressive drugs are expected to be used during the study; 6. a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance; 7. other important medical or physiological conditions (such as pregnancy or breastfeeding status); 8. patients who are known to be allergic to the drugs used in this study; 9. patients refuse or are unable to sign the informed consent.
Contact & Investigator
Guangying Zhu, M.D.
PRINCIPAL INVESTIGATOR
China-Japan Friendship Hospital
Frequently Asked Questions
Who can join the NCT06173219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06173219 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06173219 currently recruiting?
Yes, NCT06173219 is actively recruiting participants. Contact the research team at zryyfa@163.com for enrollment information.
Where is the NCT06173219 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06173219 clinical trial?
NCT06173219 is sponsored by China-Japan Friendship Hospital. The principal investigator is Guangying Zhu, M.D. at China-Japan Friendship Hospital. The trial plans to enroll 38 participants.