Carbon ion radiotherapy with chemotherapy for advanced thymic tumors

Prospective Phase II Clinical Study of Carbon Ion Radiotherapy Combined With Chemotherapy for Thymic Epithelial Tumors

This study is testing if combining carbon ion radiotherapy with chemotherapy can help people with advanced thymic tumors live longer and feel better.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Proton and Heavy Ion Center (other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06186726 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of carbon ion radiotherapy combined with chemotherapy in patients with inoperable locally advanced or advanced thymic epithelial tumors. Participants will receive a specific dose of carbon ion radiotherapy along with a platinum-based chemotherapy regimen for at least four cycles. The study aims to assess progression-free survival, local control rates, overall survival, and treatment-related toxicity. Patients must have evaluable lesions that can be targeted by the radiation treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with inoperable locally advanced or advanced thymic epithelial tumors who have not previously undergone thoracic radiation therapy.

Not a fit: Patients with operable tumors or those who have received prior thoracic radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced thymic tumors that are currently difficult to treat.

How similar studies have performed: While carbon ion therapy is a novel approach, similar studies have shown promise in treating other types of tumors, indicating potential for success in this context.

Eligibility criteria

Inclusion Criteria:

* Patients with inoperable locally advanced or advanced thymic epithelial tumor who have been confirmed pathologically, and have not received thoracic radiation therapy before coming to our hospital, and have radiologically evaluable lesions, and all visible lesions can be included in the radiation target area during this treatment.
* Between the ages of 18 and 70.
* Sign the informed consent.
* ECOG general status score of 0-2 .
* The expected survival is greater than or equal to 6 months.
* Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1\>25%, DLCO\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \<1.5 times the upper limit of normal value, and AST, ALT\<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein \<2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.

Exclusion Criteria:

* Complicated with other malignant tumors that have not been controlled.
* With large quantity of pleural effusion or pericardial effusion.
* Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
* Chest radiation therapy or radioactive particle implantation history.
* Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
* Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
* HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
* A history of mental illness may hinder the completion of treatment.
* With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
* Other circumstances that the physician considers inappropriate to participate in clinical study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jian Chen, M.D. — Shanghai Proton and Heavy Ion Center
• Study coordinator: Jing Li

Conditions: Carbon Ion Radiotherapy, Thymoma, Thymic Carcinoma, Radiotherapy, Chemotherapy