NCT06775678 Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer
| NCT ID | NCT06775678 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Lung Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-01-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2024-10-01 with a primary completion date of 2027-01-30.
⚠ 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 purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form. 2. Be at least 18 years old. 3. Have a Karnofsky Performance Status (KPS) score of 70 or higher and an expected survival of more than 3 months. 4. Have histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma. 5. Have received prior immunotherapy and experienced disease progression. 6. The site targeted for radiotherapy has not been previously irradiated or it has been at least 6 months since the last radiotherapy. Exclusion Criteria: 1. The patient has lesions that are not suitable for radiotherapy: malignant pleural effusion, ascites, meningeal metastasis, etc. 2. The patient has other serious comorbidities, such as myocardial infarction occurring within 6 months, severe arrhythmia, mental illness, etc., is unable to complete the treatment, or has an expected survival period of less than 3 months. 3. The patient has severe organ dysfunction, such as liver failure, cardiopulmonary failure, etc., and is difficult to tolerate radiotherapy. 4. The patient currently has a severe infection. 5. The patient has a known or suspected active autoimmune disease (congenital or acquired), such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Patients with vitiligo or those with cured childhood asthma can be included; patients with type 1 diabetes who have good insulin control can also be included). 6. The patient has experienced grade 3 or above cardiac or liver toxicity reactions or grade 4 toxicity reactions in other organs during previous immunotherapy. 7. Other situations where reviewers consider there are sufficient reasons for disqualification from the registered study: such as potential situations inconsistent with the clinical protocol.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06775678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancers. 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 NCT06775678 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06775678 currently recruiting?
Yes, NCT06775678 is actively recruiting participants. Contact the research team at liuningbo@tjmuch.com for enrollment information.
Where is the NCT06775678 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06775678 clinical trial?
NCT06775678 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 84 participants.
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