Phase I Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Tumors

NCT07744074 | Recruiting DMC

• 1 other identifier: IRB-2026-727(IIT)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicities

  To determine the dose-limiting toxicities (DLTs) of carbon ion - lattice radiotherapy (CI-LRT) in this population.

  90 days

Study Arms (1)

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

Radiation: Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors

Interventions

Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors RADIATION

Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors

Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ji Yongling: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 30696472 BACKGROUND

• Tubin 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.

  PMID: 35565361 BACKGROUND

• Duriseti 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.

  PMID: 34875286 BACKGROUND

• Kavanaugh 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.

  PMID: 34896459 BACKGROUND

• Li 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.

  PMID: 38110104 BACKGROUND

Study Officials

• Yongling Ji, MD

  Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongling Ji, MD

CONTACT

0086-571-88122088; Jiyl@zjcc.org.cn

Qingren Lin

CONTACT

0086-571-88122088; linqr@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 4, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)