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Tianjin Medical University Cancer Institute and HospitalSpatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer Phase 2 84 Immunotherapy
Clinical Trial NCT06775678 is designed to study Treatment for Lung Cancers, Radiation Treatment for Tumors. It is a Phase 2 interventional study that is recruiting, having started on 1 October 2024, with plans to enroll 84 participants. Led by Tianjin Medical University Cancer Institute and Hospital, it is expected to complete by 28 January 2028. The latest data from ClinicalTrials.gov was last updated on 17 June 2025.
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, t...Show More
Detailed Description
The eligible subjects were randomly divided into the experimental group and the control group according to the proportion of 1:1. The experimental group was treated with space fractionation radiotherapy for a single lesion, with a prescription dose of 800-1200cGy × 3f in the high-dose area and 100-300cGy × 5f in the low-dose area. All other irradiable metastatic foci were given low-dose radiotherapy (brain and bone m...Show More
Official Title
A Single-centre Phase II Clinical Study of Spatially Fragmentation Radiotherapy Combined With Low-dose Radiotherapy for Reversal of Immunotherapy Combined With Chemotherapy Resistance in Locally Advanced Inoperable or Advanced Non-small Cell Lung Cancer
Conditions
Lung CancersRadiation Treatment for TumorsOther Study IDs
- E20240009
NCT ID Number
Start Date (Actual)
2024-10-01
Last Update Posted
2025-06-17
Completion Date (Estimated)
2028-01-28
Enrollment (Estimated)
84
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Spatially Fractionated Radiation Treatment
low dose radiotherapy
Lung Cancers
Immunotherapy
low dose radiotherapy
Lung Cancers
Immunotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalexperimental group 1. Patients received dose-specific irradiation using a medical linear accelerator to create each sphere of approximately 0.5 to 1.5 cm in diameter within the gross tumour volume (GTV) of the largest tumour, with spheres spaced 2.0 to 5.0 cm apart from each other as the high-dose area; the rest of the GTV was used as the low-dose area.
For a single lesion, spatially divided radiotherapy was given, with the prescri...Show More | Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy |
Active Comparatorcontrol group The control group only received conventional radiotherapy for chest or other lesions, followed by immunotherapy and chemotherapy according to the tumor stage, tolerance and genetic characteristics of the patients | Conventional fractionated radiotherapy Conventional fractionated radiotherapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective response rate | From enrollment to the end of treatment at 6 mouths |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Disease control rate | From enrollment to the end of treatment at 6 mouths | |
Progression free survival | From enrollment to the end of treatment at 6 mouths | |
Overall survival | From enrollment to the end of treatment at 6 mouths | |
Adverse Event | From enrollment to the end of treatment at 6 mouths |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Sign the informed consent form.
- Be at least 18 years old.
- Have a Karnofsky Performance Status (KPS) score of 70 or higher and an expected survival of more than 3 months.
- Have histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma.
- Have received prior immunotherapy and experienced disease progression.
- The site targeted for radiotherapy has not been previously irradiated or it has been at least 6 months since the last radiotherapy.
- The patient has lesions that are not suitable for radiotherapy: malignant pleural effusion, ascites, meningeal metastasis, etc.
- 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.
- The patient has severe organ dysfunction, such as liver failure, cardiopulmonary failure, etc., and is difficult to tolerate radiotherapy.
- The patient currently has a severe infection.
- 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).
- The patient has experienced grade 3 or above cardiac or liver toxicity reactions or grade 4 toxicity reactions in other organs during previous immunotherapy.
- Other situations where reviewers consider there are sufficient reasons for disqualification from the registered study: such as potential situations inconsistent with the clinical protocol.
Tianjin Medical University Cancer Institute and Hospital378 active studies to exploreStudy Central Contact
Contact: Ningbo Liu, doctor, +86 15602036608, [email protected]
Contact: Ningbo Liu, doctor, +8615602036608
1 Study Locations in 1 Countries
Tianjin Municipality
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin Municipality, 300000, China
Ningbo Liu, Contact, +8615602036608, [email protected]
Recruiting