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

ConditionCarbon Ion Radiotheray

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJi Yongling

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose-Limiting Toxicities

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

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ji Yongling

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov

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