Carbon ion lattice radiotherapy for large thoracic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first prospective study that combines induction chemoimmunotherapy with carbon ion lattice radiotherapy followed by consolidation immunotherapy for patients with unresectable thoracic tumors. Eligible participants are adults with large thoracic tumors (≥4.5 cm) who have exhausted standard treatments. Tissue, blood, urine, and stool samples will be collected to identify biomarkers of response. The trial assesses safety and preliminary efficacy of this multimodal approach using heavy-ion radiotherapy. Enrollment is at Zhejiang Cancer Hospital in Hangzhou, with strict eligibility to avoid tumors near critical organs or prior conflicting radiotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yongling Ji, MD — Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022
• Study coordinator: Yongling Ji, MD
• Email: Jiyl@zjcc.org.cn
• Phone: 0086-571-88122088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.