Lung CancersPhase 2NCT06775678
Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy and Conventional fractionated radiotherapy in people with Lung Cancers and Radiation Treatment for Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancers, Radiation Treatment for Tumors
- What is being tested?
- Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy and Conventional fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 28 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ningbo Liu, doctor contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000
Ningbo Liu, +8615602036608, liuningbo@tjmuch.com
About this study
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
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.
Read the 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 metastases were given palliative radiotherapy according to clinical routine, but not within the range of low-dose radiotherapy). The prescription dose was 100-300cGy × 5f. Chemotherapy combined with immunotherapy was given during or within 1 week after radiotherapy. 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. Peripheral blood routine, immune cell (lymphocyte) subsets and related cytokines were detected before radiotherapy, on the day after radiotherapy and within 7 days after 1 cycle of immunotherapy. Before radiotherapy and after 1 cycle of immunotherapy, the metastatic focus was biopsied, fixed with 4% formaldehyde for 12-24 hours, dehydrated by gradient alcohol in the dehydrator, and finally embedded in paraffin to make wax blocks for preservation. The toxic and side effects of the treatment were recorded in detail, and the symptomatic treatment and detailed records can be made according to the severity. Patients with severe adverse reactions (SAE) will stop treatment and report to the research center for inclusion in the statistics. The toxicity and side effects were evaluated by CTCAE5.0 standard, and the long-term side effects were evaluated by RTOG long-term toxicity evaluation criteria.
- Conditions
- Lung Cancers, Radiation Treatment for Tumors
- Being tested
- Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy, Conventional fractionated radiotherapy
- Keywords
- Spatially Fractionated Radiation Treatment, low dose radiotherapy, Lung Cancers, Immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiation Therapy Combined With Low-dose RadiotherapyRadiation
Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy
Conventional fractionated radiotherapyRadiation
Conventional fractionated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 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 prescribed dose for the high-dose area: 800-1200cGy×3f, and the prescribed dose for the low-dose area: 100-300cGy×5f; all the remaining irradiable metastatic foci were given low-dose radiotherapy (palliative radiotherapy was given to the brain and bone metastases in accordance with the clinical routine, and was excluded from the scope of low-dose radiotherapy), with the prescribed dos
2. During or within 1 week after radiotherapy, chemotherapy combined with immunotherapy was carried out according to the physical, pathological and genetic detection of the patients. Receives: Radiation: Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy |
| control group | Active comparator | 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 Receives: Radiation: Conventional fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From enrollment to the end of treatment at 6 mouths
Secondary outcomes (4)
Disease control rate
Measured: From enrollment to the end of treatment at 6 mouths
Progression free survival
Measured: From enrollment to the end of treatment at 6 mouths
Overall survival
Measured: From enrollment to the end of treatment at 6 mouths
Adverse Event
Measured: From enrollment to the end of treatment at 6 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775678
- Sponsor's protocol ID
- E20240009
- Status last verified
- May 2025
- First submitted
- 8 Jan 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou Y, Li Y, Zhu H, Yang S, Yang C, Jiang S, Shen S, Zhao L, Luo J, Yuan Z, Liu N. Preliminary results from a phase II trial of spatially fractionated radiotherapy combined with immunotherapy and anti-angiogenic therapy in patients with bulky solid tumors: early evidence of promising efficacy and favorable safety. Radiat Oncol. 2026 Apr 30;21(1):79. doi: 10.1186/s13014-026-02841-w.
PubMed 42063096
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06775678
- Acronym / sponsor ID
- E20240009
- Conditions
- Lung Cancers, Radiation Treatment for Tumors
- Keywords
- Spatially Fractionated Radiation Treatment, low dose radiotherapy, Lung Cancers, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 metastases were given palliative radiotherapy according to clinical routine, but not within the range of low-dose radiotherapy). The prescription dose was 100-300cGy × 5f. Chemotherapy combined with immunotherapy was given during or within 1 week after radiotherapy. 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. Peripheral blood routine, immune cell (lymphocyte) subsets and related cytokines were detected before radiotherapy, on the day after radiotherapy and within 7 days after 1 cycle of immunotherapy. Before radiotherapy and after 1 cycle of immunotherapy, the metastatic focus was biopsied, fixed with 4% formaldehyde for 12-24 hours, dehydrated by gradient alcohol in the dehydrator, and finally embedded in paraffin to make wax blocks for preservation. The toxic and side effects of the treatment were recorded in detail, and the symptomatic treatment and detailed records can be made according to the severity. Patients with severe adverse reactions (SAE) will stop treatment and report to the research center for inclusion in the statistics. The toxicity and side effects were evaluated by CTCAE5.0 standard, and the long-term side effects were evaluated by RTOG long-term toxicity evaluation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Radiation: Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy1. 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 prescribed dose for the high-dose area: 800-1200cGy×3f, and the prescribed dose for the low-dose area: 100-300cGy×5f; all the remaining irradiable metastatic foci were given low-dose radiotherapy (palliative radiotherapy was given to the brain and bone metastases in accordance with the clinical routine, and was excluded from the scope of low-dose radiotherapy), with the prescribed dos 2. During or within 1 week after radiotherapy, chemotherapy combined with immunotherapy was carried out according to the physical, pathological and genetic detection of the patients. |
| control group | Active comparator | Radiation: Conventional fractionated radiotherapyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spatially Fractionated Radiation Therapy Combined With Low-dose RadiotherapySpatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy | Radiation | experimental group |
| Conventional fractionated radiotherapyConventional fractionated radiotherapy | Radiation | control group |
Primary outcome
Objective response rate
Time frame: From enrollment to the end of treatment at 6 mouths
4 secondary outcomes
Disease control rate
Time frame: From enrollment to the end of treatment at 6 mouths
Progression free survival
Time frame: From enrollment to the end of treatment at 6 mouths
Overall survival
Time frame: From enrollment to the end of treatment at 6 mouths
Adverse Event
Time frame: From enrollment to the end of treatment at 6 mouths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 42063096Zhou Y, Li Y, Zhu H, Yang S, Yang C, Jiang S, Shen S, Zhao L, Luo J, Yuan Z, Liu N. Preliminary results from a phase II trial of spatially fractionated radiotherapy combined with immunotherapy and anti-angiogenic therapy in patients with bulky solid tumors: early evidence of promising efficacy and favorable safety. Radiat Oncol. 2026 Apr 30;21(1):79. doi: 10.1186/s13014-026-02841-w.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ningbo Liu, doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy and Conventional fractionated radiotherapy in people with Lung Cancers and Radiation Treatment for Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ningbo Liu, doctor (+86 15602036608, liuningbo@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From enrollment to the end of treatment at 6 mouths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.