Carbon Ion RadiotherayCILAT-INCT07744074
Phase I Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Tumors
A study testing Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors in people with Carbon Ion Radiotheray, run by Ji Yongling at 1 site in China.
Trial summary
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Ion Radiotheray
- What is being tested?
- Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- Age ≥ 18 years old;
- Pathologically confirmed thoracic solid malignant tumors;
- Local recurrence or failure of prior standard therapies (including surgery, radiotherapy, systemic therapy, etc.), deemed unsuitable for or lacking standard treatment options following Multidisciplinary Team (MDT) evaluation, and planned to receive heavy-ion radiotherapy；
- Maximum diameter of the target lesion ≥ 4.5 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Life expectancy ≥ 6 months;
- Signed informed consent.
Who cannot join
- Tumors adjacent to critical organs at risk (OARs) where dose constraints cannot be met through plan optimization;
- Prior radiotherapy to the intended treatment area, where re-irradiation would fail to meet normal tissue dose constraints;
- Presence of recognized standard treatment options for which the patient is eligible (e.g., radical surgery, concurrent chemoradiotherapy, or standard systemic therapy);
- Primary hematologic malignancies;
- Uncontrolled severe comorbidities, including active infections, unstable cardiovascular or cerebrovascular diseases, and severe hepatic or renal insufficiency;
- Other diseases deemed by the investigator to compromise patient safety;
- Psychiatric disorders or cognitive impairment that would prevent cooperation with treatment;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Yongling Ji, MD, 0086-571-88122088, jiyl@zjcc.org.cn
About this study
Official title: A Single-Arm Phase I Clinical Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Malignant Tumors
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
- Conditions
- Carbon Ion Radiotheray
- Being tested
- Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumorsRadiation
Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
| Study group | Role | What they receive |
|---|---|---|
| Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors | Experimental | Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors Receives: Radiation: Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicities
To determine the dose-limiting toxicities (DLTs) of carbon ion - lattice radiotherapy (CI-LRT) in this population.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start26 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carbon Ion RadiotherayStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Yongling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Yongling, Zhejiang Cancer Hospital
- Investigators
- Yongling Ji, MD, Principal investigator, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744074
- Sponsor's protocol ID
- IRB-2026-727(IIT)
- Acronym
- CILAT-I
- Status last verified
- May 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tubin S, Popper HH, Brcic L. Novel stereotactic body radiation therapy (SBRT)-based partial tumor irradiation targeting hypoxic segment of bulky tumors (SBRT-PATHY): improvement of the radiotherapy outcome by exploiting the bystander and abscopal effects. Radiat Oncol. 2019 Jan 29;14(1):21. doi: 10.1186/s13014-019-1227-y.
PubMed 30696472Tubin S, Fossati P, Carlino A, Martino G, Gora J, Stock M, Hug E. Novel Carbon Ion and Proton Partial Irradiation of Recurrent Unresectable Bulky Tumors (Particle-PATHY): Early Indication of Effectiveness and Safety. Cancers (Basel). 2022 Apr 29;14(9):2232. doi: 10.3390/cancers14092232.
PubMed 35565361Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4.
PubMed 34875286Kavanaugh JA, Spraker MB, Duriseti S, Basarabescu F, Price A, Goddu M, Knutson N, Prusator M, Robinson C, Mazur T. LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. Radiother Oncol. 2022 Feb;167:172-178. doi: 10.1016/j.radonc.2021.12.003. Epub 2021 Dec 9.
PubMed 34896459Li H, Mayr NA, Griffin RJ, Zhang H, Pokhrel D, Grams M, Penagaricano J, Chang S, Spraker MB, Kavanaugh J, Lin L, Sheikh K, Mossahebi S, Simone CB, Roberge D, Snider JW, Sabouri P, Molineu A, Xiao Y, Benedict SH. Overview and Recommendations for Prospective Multi-institutional Spatially Fractionated Radiation Therapy Clinical Trials. Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):737-749. doi: 10.1016/j.ijrobp.2023.12.013. Epub 2023 Dec 17.
PubMed 38110104
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase I Clinical Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Malignant Tumors
- ClinicalTrials.gov ID
- NCT07744074
- Acronym / sponsor ID
- CILAT-I / IRB-2026-727(IIT)
- Conditions
- Carbon Ion Radiotheray
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ji YonglingUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (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.
This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors | Experimental | Radiation: Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumorsCarbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old;
- Pathologically confirmed thoracic solid malignant tumors;
- Local recurrence or failure of prior standard therapies (including surgery, radiotherapy, systemic therapy, etc.), deemed unsuitable for or lacking standard treatment options following Multidisciplinary Team (MDT) evaluation, and planned to receive heavy-ion radiotherapy；
- Maximum diameter of the target lesion ≥ 4.5 cm;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Key exclusion criteria (8 listed)
- Tumors adjacent to critical organs at risk (OARs) where dose constraints cannot be met through plan optimization;
- Prior radiotherapy to the intended treatment area, where re-irradiation would fail to meet normal tissue dose constraints;
- Presence of recognized standard treatment options for which the patient is eligible (e.g., radical surgery, concurrent chemoradiotherapy, or standard systemic therapy);
- Primary hematologic malignancies;
- Uncontrolled severe comorbidities, including active infections, unstable cardiovascular or cerebrovascular diseases, and severe hepatic or renal insufficiency;
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 |
|---|---|---|
| Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumorsCarbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors | Radiation | Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors |
Primary outcome
Dose-Limiting Toxicities
Time frame: 90 days
To determine the dose-limiting toxicities (DLTs) of carbon ion - lattice radiotherapy (CI-LRT) in this population.
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 4 Aug 2026.
- Background: PubMed 30696472Tubin S, Popper HH, Brcic L. Novel stereotactic body radiation therapy (SBRT)-based partial tumor irradiation targeting hypoxic segment of bulky tumors (SBRT-PATHY): improvement of the radiotherapy outcome by exploiting the bystander and abscopal effects. Radiat Oncol. 2019 Jan 29;14(1):21. doi: 10.1186/s13014-019-1227-y.
- Background: PubMed 35565361Tubin S, Fossati P, Carlino A, Martino G, Gora J, Stock M, Hug E. Novel Carbon Ion and Proton Partial Irradiation of Recurrent Unresectable Bulky Tumors (Particle-PATHY): Early Indication of Effectiveness and Safety. Cancers (Basel). 2022 Apr 29;14(9):2232. doi: 10.3390/cancers14092232.
- Background: PubMed 34875286Duriseti S, Kavanaugh JA, Szymanski J, Huang Y, Basarabescu F, Chaudhuri A, Henke L, Samson P, Lin A, Robinson C, Spraker MB. LITE SABR M1: A phase I trial of Lattice stereotactic body radiotherapy for large tumors. Radiother Oncol. 2022 Feb;167:317-322. doi: 10.1016/j.radonc.2021.11.023. Epub 2021 Dec 4.
- Background: PubMed 34896459Kavanaugh JA, Spraker MB, Duriseti S, Basarabescu F, Price A, Goddu M, Knutson N, Prusator M, Robinson C, Mazur T. LITE SABR M1: Planning design and dosimetric endpoints for a phase I trial of lattice SBRT. Radiother Oncol. 2022 Feb;167:172-178. doi: 10.1016/j.radonc.2021.12.003. Epub 2021 Dec 9.
- Background: PubMed 38110104Li H, Mayr NA, Griffin RJ, Zhang H, Pokhrel D, Grams M, Penagaricano J, Chang S, Spraker MB, Kavanaugh J, Lin L, Sheikh K, Mossahebi S, Simone CB, Roberge D, Snider JW, Sabouri P, Molineu A, Xiao Y, Benedict SH. Overview and Recommendations for Prospective Multi-institutional Spatially Fractionated Radiation Therapy Clinical Trials. Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):737-749. doi: 10.1016/j.ijrobp.2023.12.013. Epub 2023 Dec 17.
- Individual participant dataSharing planned: No
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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.
Yongling Ji, MD principal investigator
Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors in people with Carbon Ion Radiotheray, run by Ji Yongling 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 7 inclusion and 8 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 4 Aug 2026. 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.
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 Yongling Ji, MD (0086-571-88122088, Jiyl@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicities (time frame: 90 days). 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 NCT07744074, which also lists 5 linked publications.
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 4 Aug 2026.