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

A Single-Arm Phase I Clinical Study of Carbon-Ion Lattice Radiotherapy for Large Thoracic Malignant Tumors

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07744074

Acronym

CILAT-I

Enrollment

Registered

2026-08-04

Start date

2026-05-26

Completion date

2028-12-31

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Ion Radiotheray

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years old; 2. Pathologically confirmed thoracic solid malignant tumors; 3. 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； 4. Maximum diameter of the target lesion ≥ 4.5 cm; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Life expectancy ≥ 6 months; 7. Signed informed consent.

Exclusion criteria

1. Tumors adjacent to critical organs at risk (OARs) where dose constraints cannot be met through plan optimization; 2. Prior radiotherapy to the intended treatment area, where re-irradiation would fail to meet normal tissue dose constraints; 3. Presence of recognized standard treatment options for which the patient is eligible (e.g., radical surgery, concurrent chemoradiotherapy, or standard systemic therapy); 4. Primary hematologic malignancies; 5. Uncontrolled severe comorbidities, including active infections, unstable cardiovascular or cerebrovascular diseases, and severe hepatic or renal insufficiency; 6. Other diseases deemed by the investigator to compromise patient safety; 7. Psychiatric disorders or cognitive impairment that would prevent cooperation with treatment; 8. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame	Description
Dose-Limiting Toxicities	90 days	To determine the dose-limiting toxicities (DLTs) of carbon ion - lattice radiotherapy (CI-LRT) in this population.

Countries

China

Contacts

CONTACTYongling Ji, MD

Jiyl@zjcc.org.cn0086-571-88122088

CONTACTQingren Lin

linqr@zjcc.org.cn0086-571-88122088

PRINCIPAL_INVESTIGATORYongling Ji, MD

Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026