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Prospective clinical study of multimodal X/ gamma-ray radiotherapy system for solid tumors

Prospective clinical study of multimodal X/ gamma-ray radiotherapy system for solid tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079261
Enrollment
Unknown
Registered
2023-12-28
Start date
2023-12-31
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Solid tumor

Interventions

treatment group:Individualized radiotherapy regimens (X/ gamma-ray fusion regimens or single modalities, such as treatment modalities, prescribed doses, and grading, etc.) are developed according to t

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Participants must meet all of the following inclusion criteria to be enrolled in the study: (1) Patients whose organ function has been determined by the investigator and who are considered suitable for X/ gamma radiation therapy system by a joint consultation of senior radiotherapy experts. (2) The treatment plans of all patients were compared with simultaneous dosing plans, and the radiotherapy plans of the X/ gamma-ray radiotherapy system were no worse than those of the VMAT plan. (3) The subjects are aged 18-80 years old (including 18 years old and 80 years old), regardless of gender. (4) The subject is confirmed to have a primary or secondary tumor that can be radiographically detected by CT or MRI at: A. Head and neck: including nasopharyngeal carcinoma, head and neck squamous cell carcinoma, salivary gland tumor, brain metastatic cancer, etc. B. Chest: including lung cancer, esophageal cancer, mediastinal tumor, etc. C. Abdomen and pelvis: including liver cancer and liver metastatic cancer, urinary system tumor, reproductive system tumor, rectal cancer, pelvis and abdominal lymph node metastatic cancer; D. Spine and limbs: including bone metastases. (5) There is at least one measurable lesion. (6) As judged by the investigator, the expected survival of the subjects was more than 6 months. (7) KPS score =70 points (KPS scoring standards refer to Annex 3[]). (8) Voluntarily sign informed consent, understand and accept the duration of the study, and be able and willing to comply with all requirements, including scheduled treatment, follow-up, and other study procedures.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be enrolled in this study: (1) Subjects with contraindications to radiotherapy; (2) Patients who had participated in other interventional clinical trials within 30 days prior to screening; (3) Pregnant or lactating female subjects; (4) Subjects, whether male or female, who plan to become pregnant during the treatment period or do not want to use contraception; (5) Subjects who have developed cachexia; (6) serious insufficiency of vital organs (such as brain, heart, lung, liver, kidney, etc.); (7) White blood cells < 2.0×109/L or platelets < 50×109/L or hemoglobin < 80 g/L; (8) Subjects that the investigator considers inappropriate to participate in this clinical study.(YNMT)·

Design outcomes

Primary

MeasureTime frame
Effective rate of 3 months after treatment;

Secondary

MeasureTime frame
Treatment response rate;LRFS;DMFS;OS;

Countries

China

Contacts

Public ContactLina Zhao

Xijing Hospital

zhaolina@fmmu.edu.cn+86 135 7255 3455

Outcome results

None listed

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