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
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
Treatments tested in this trial
- Carbon ion - Lattice radioIon Lattice Radiation Therapy for Thoracic bulky solid tumors
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Ji Yongling
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov