ClinicalTrials.gg
RecruitingNCT06186726Updated Jun 13, 2025

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

A Phase 2 interventional study of carbon ion radiotherapy in Carbon Ion Radiotherapy, Thymoma, Thymic Carcinoma, Radiotherapy, Chemotherapy, sponsored by Jian Chen. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Jian Chen · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To observe the efficacy of carbon ion radiotherapy combined with chemotherapy in the treatment of inoperable locally advanced or advanced (all visible lesions can be included in the radiation target area in this treatment) primary thymic epithelial tumor who have no thorax radiotherapy histroy. The patients will receive 72GyE/18fractions of carbon ion radiotherapy. Combined with platinum-containing schemes (including etoposide combined with cisplatin or carboplatin or loplatin or nedaplatin, paclitaxel combined with cisplatin or carboplatin or loplatin or nedaplatin, etc.); Docetaxel combined with cisplatin or carboplatin or loplatin or nedaplatin) for at least 4 cycles. Progression-free survival, local control rate, overall survival and toxicity were calculated.

02

Conditions studied

  • Carbon Ion Radiotherapy, Thymoma, Thymic Carcinoma, Radiotherapy, Chemotherapy

Browse trials for

03

In context

Thymoma

133 studies on the registry are indexed under Thymoma; 37 are open to participants now.

This study's planned enrollment of 48 is close to the median of 44 across 108 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Jian Chen is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • general status score of 0-2 .
  • The expected survival is greater than or equal to 6 months.
  • Adequate organ function: 1). Blood function: (ANC) ≥1.5 x 109/L, count ≥80 x 109/L, ≥9 g/dL 2). Lung function: >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 \<1.5 times the value, and , 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 ≥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

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.
  • 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 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.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Study arm

    The patients received 72GyE/18 fractions of carbon ion radiotherapy. Combined with platinum-containing schemes (including etoposide combined with cisplatin or carboplatin or loplatin or nedaplatin, paclitaxel combined with cisplatin or carboplatin or loplatin or nedaplatin, etc.); Docetaxel combined with cisplatin or carboplatin or loplatin or nedaplatin) for at least 4 cycles

    Radiation: carbon ion radiotherapy

Interventions

  • Radiationcarbon ion radiotherapy

    The patients received 72GyE/18 doses of carbon ion radiotherapy.

06

What researchers measure

Primary outcomes

  1. Disease progression-free survival rate

    Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up

    Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

  1. Local control rate

    Local control rate was defined from the start of carbon ion radiotherapy till the date of local failure or the last follow-up.

    Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months

  2. Overall survival rate

    Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up.

    Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.

  3. Incidence of Treatment-induced Adverse Events

    Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.

    Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.

Of 32 phase 2 interventional studies under Thymoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 96. This study's planned 35 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2023
First posted
Jan 2, 2024
StartActual
Jan 26, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2029
Last update
Jun 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06186726
Lead sponsor
Jian Chen
Responsible party
Jian Chen (Clinical Professor, Shanghai Proton and Heavy Ion Center) — Sponsor-investigator
First posted
Jan 2, 2024
Start date
Jan 26, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 13, 2025

Study contacts

Jing Li
Contact
jing.li@sphic.org.cn
86-21-38296678
Jian Chen, M.D.
principal investigator · Shanghai Proton and Heavy Ion Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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