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Clinical trial to evaluate the safety and efficacy of medical electron linear accelerator for tumor radiation therapy

Clinical trial to evaluate the safety and efficacy of medical electron linear accelerator for tumor radiation therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082631
Enrollment
Unknown
Registered
2024-04-02
Start date
2024-06-07
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

1. Head and neck
2. Breasts
3. Abdomen
4. Abdomen
5. Pelvic cavity
6. Spine and limbs.:Radiation therapy

Sponsors

Cancer Hospital Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following inclusion criteria without any of the exclusion criteria described below to be enrolled in this clinical trial: (1) Age between 18 years (inclusive) and 80 years (inclusive), gender is not limited; (2) Female subjects of childbearing age, pregnancy test negative; (3) Pathological diagnosis of malignant tumor, the size of non-surgically resected lesion can be measured by imaging, and the subject has at least one measurable lesion as defined by RECIST1.1; (4) Confirmed by imaging and other effective diagnostic means of definite location occupying lesions; (5) Expected survival of 6 months or more; (6) No surgical treatment is required in radiotherapy; (7) Have read the subject's informed letter, agreed to the treatment and signed the written informed consent, are willing and able to follow up in time according to the requirements of the program, and perform CT/MRI imaging before and after radiotherapy if necessary.

Exclusion criteria

Exclusion criteria: In case screening, participants who meet any of the following conditions will be excluded from this clinical trial: (1) There are contraindications to radiotherapy; (2) Implantation of pacemakers or other metal prostheses within the scope of radiotherapy; (3) The same tumor target has received two or more radiation treatments (including conventional photonics, offspring, radiosurgery, or intertissue implantation of radioactive particles); (4) Tumor interventional therapy was performed on the same lesion within 6 months before treatment; (5) those who have received antitumor therapy in the previous period and the toxic reaction has not recovered (according to NCI-CTCAE 5.0, the toxic reaction has not recovered to 180mmHg and/or diastolic blood pressure >mmHg in hypertensive patients after radiotherapy; (10) HbA1c>9% in patients with diabetes after treatment; (11) Major surgery within 28 days prior to treatment (refer to the level 3 and level 4 operations stipulated in the "Administrative Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009); (12) Any of the following cardiac lesions at enrollment: New York Heart Society Functional Scale (NYHA) Class III to IV heart disease; Angina pectoris, congestive heart failure, or myocardial infarction within 6 months prior to treatment; Prolonged QTc interval (>600 ms in men and >480 ms in women); Second degree type II, third degree AV block or PR interval >250msc; Left ventricular ejection fraction (LVEF) <50%; (13) Persons with combined mental illness and drug or alcohol dependence; (14) Participating in clinical trials of other interventional drugs, biologics or devices within 30 days prior to enrollment; (15) lack of full or limited capacity for civil conduct; (16) Dose limitation of the patient's organ at risk, which does not meet the dosing requirements of the radiotherapy plan in the trial; (17) had other malignant tumors (excluding non-malignant melanoma skin cancer or non-invasive cervical cancer) within 5 years prior to enrollment; (18) severe emaciation or obvious cachexia; (19) White blood cell count less than 2.0×10^9/L, platelet count less than 50×10^9/L, hemoglobin less than 80g/L; (20) Esophageal cancer with deep ulcer and perforation, lung cancer with a large number of pleural fluid, abdominal tumor with a large number of ascites; (21) Patients with other diseases co-existing in the affected area that may significantly affect the evaluation of efficacy; (22) Those who do not sign informed consent and have difficulty in communication; (23) Other conditions deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Tumor control probability;CT impact assessment;Overall stability evaluation;

Secondary

MeasureTime frame
Evaluation of radiotherapy software;Evaluation of the effect of radiotherapy planning;Measurement calculation accuracy evaluation;

Countries

China

Contacts

Public ContactLi Yexiong

Cancer Hospital Chinese Academy of Medical Science

yexiong12@163.com+86 138 0110 3877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026