Clinical Study of Carbon Ion Radiotherapy for High-grade Glioma

Inclusion Criteria:

1. Age ≥14 years and ≤80 years;

2. Indications: According to the criteria of the 5th edition of WHO Classification ofCentral Nervous System Tumors published in 2021, histological characteristics andmolecular phenotype were integrated, and the molecular phenotype was IDH wild-typeglioma and IDH mutant WHO Grade Ⅲ and Ⅳ glioma. They mainly include: IDH wild-typelow-grade glioma (Grade 4 astrocytoma according to the 2021 WHO classificationdefinition); Anaplastic Astrocytoma, AA; anaplastic astrocytoma, AA; AnaplasticOligodendroglioma, AOG; anaplastic oligodendroglioma, AOG; AnaplasticOligoastrocytoma, AOA; anaplastic oligoastrocytoma, AOA; Glioblastoma Multiforme,GBM. Regardless of surgical completeness, i.e. after total, subtotal, or partialresection, and after stereotactic or craniotomy.

3. No distant or intraspinal spread and metastasis; A single or two intracraniallesions may be covered by the same radiotherapy plan.

4. The treatment conditions before this radiotherapy were as follows: Firstradiotherapy: no interventional, photodynamic or other tumor ablation was performedwithin 4 weeks before this radiotherapy; The operative wound has fully healed.

5. Can accept MRI and enhanced CT examination, and there are no metal artifacts in CTV;

6. No history of other malignant tumors (except cured skin cancer and stage 0 cervicalcancer);

7. Liver function, kidney function and bone marrow function were basically normal (ALTand AST < 1.5 times of high normal value (ULN), bilirubin < 1.5×ULN; Adultendogenous creatinine clearance rate of 60ml/min or serum creatinine SCR≤140μmoI/L,BUN≤6.8mmol/L; Hemoglobin level >9 g/dL; White blood cell count ≥3.0109/L; Plateletcount ≥100109/L;)

8. Good physical condition, i.e. ECOG (Eastern United States Oncology CollaborationGroup) 0~2; There were no complications such as severe pulmonary hypertension,cardiovascular disease, peripheral vascular disease, and severe chronic heartdisease that may affect radiotherapy. Cardiac function grade 1. (According to theNew York College of Cardiology Cardiac Function Scale (NYHA)

9. Adequate functions of major organs;

10. Predicted survival (after treatment) ≥6 months;

11. Informed consent has been signed by the patient or his legal representative beforeradiotherapy.

Exclusion Criteria:

1. WHOII-IV glioma unconfirmed by pathology;

2. Patients who cannot lie still for 30 minutes;

3. Secondary treatment of recurrent tumors

4. There have been distant metastases, or scattered or multiple (>2) intracraniallesions;

5. Have received conventional photon/proton/carbon ion radiotherapy to the head;

6. Have received intracranial radioactive particle implantation with metal implantsthat may affect the dose of particle radiation therapy;

7. Unable to receive MRI with claustrophobia or a pacemaker or metal implant

8. Pacemakers or other metal implants that may be interfered with normal function byhigh-energy radiation or may affect the dose of radiation target;

9. The dose limit for organs at risk cannot reach the preset safe dose limit

10. Pregnancy (confirmed by serum or urine β-HCG test) or lactation

11. losing more than 20% of your body weight within six months;

12. Persons with AIDS, including those who have received antiretroviral therapy; Activestage of syphilis;

13. Accompanied by serious comorbiditions, including uncontrolled systemic orco-existing diseases (pulmonary insufficiency, cardiovascular, pulmonary, liver,kidney, diabetes, etc.), drug or alcohol abuse, dependence, addiction, and/or mentalillness that prevent the successful implementation of the trial protocol;

14. Patients with poor compliance, including those who may not be able to complete thetreatment plan or receive prescribed follow-up and examination;

15. have had other malignant neoplasms (except cured skin cancer and stage 0 cervicalcancer);

16. There are contraindications to radiotherapy;

17. Participated in other drug clinical trials within 30 days prior to enrollment inthis study;

18. having no or limited capacity for civil conduct;

19. Any medical history that, in the investigator's judgment, might interfere with thetrial results or increase the patient's risk;

20. Any condition in which the physician considers that participation in the trial isnot appropriate, the physician determines that the patient will not benefit fromcarbon ion radiotherapy, or that there are other co-existing conditions or otherfactors that may affect carbon ion therapy.

21. Inability to understand the purpose of treatment or unwillingness/inability to signtreatment consent.