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Prospective clinical study to evaluate the safety and efficacy of SABR radiotherapy for renal cell carcinoma

Prospective clinical study to evaluate the safety and efficacy of SABR radiotherapy for metastatic and inoperable locally and locally advanced renal cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059204
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Renal cancer

Interventions

Radiation therapy group:Radiation therapy

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Renal cell carcinoma (RCC) with the following characteristics 1) Limited period RCC that cannot be operated due to the following reasons:; Localized RCC confirmed by histology is not expected to be removed after comprehensive evaluation by urologists Or after evaluation by urology department and physician, it is considered that the operation cannot be tolerated due to poor general conditions (those who are not suitable for open surgery, those who need to keep nephron as much as possible, those who have contraindications to general anesthesia, those who have serious complications, severe renal insufficiency, and simultaneous renal cell carcinoma) Or refuse to perform surgery; 2) Transferable RCC; Metastatic RCC confirmed by histology or PET/CT, or more definite metastasis considered by imaging doctors, radiotherapy departments and urologists through comprehensive evaluation of medical history, physical examination and imaging examination. 2. The expected survival period is more than 6 months; 3. Age>12 years old; 4. ECOG 0-1 points; 5. Leukocyte = 3.5 × 10 * 9/l, neutrophil = 1.5 × 10 * 9/l, platelet = 100.0 × 10 * 9/l, hemoglobin = 90g/l; 6. Informed consent of patients.

Exclusion criteria

Exclusion criteria: 1. Have a history of malignant tumor (except for skin cancer without malignant melanoma, cervical cancer in situ, and tumors that have been cured for more than 5 years); 2. Have received radiotherapy for this part; 3. Weight loss>10% within 6 months; 4. Those who have or are combined with hemorrhagic diseases; 5. Active infection; 6. Clinically obvious cardiac diseases (such as drug-controlled hypertension, unstable angina pectoris, congestive heart failure (NYHA) = Grade II, unstable symptomatic arrhythmia or = Grade II peripheral vascular disease); 7. Patients with coronary heart disease who have been receiving interventional therapy or stopped anticoagulant drugs such as aspirin for less than 6 months; 8. Those who are unable to give informed consent due to psychological, family, social and other factors.

Design outcomes

Primary

MeasureTime frame
side effects;progression-free survival,PFS;

Secondary

MeasureTime frame
objective response rate, ORR;overall survival, OS;

Contacts

Public ContactXianshu Gao

Peking University First Hospital

13911208977@139.com+86 13911208977

Outcome results

None listed

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