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Phase II clinical study of first-line drugs combined with SBRT in the treatment of oligoprogressive renal cell carcinoma

Phase II clinical study of first-line drugs combined with SBRT in the treatment of oligoprogressive renal cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032947
Enrollment
Unknown
Registered
2020-05-16
Start date
2022-05-31
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

Renal Cell Carcinoma

Interventions

Case series:SBRT

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years who voluntarily participated in the clinical study; 2. Patients whose nephrotic focus has been treated or can be treated at the same time; 3. Patients with ECoG score of 0-2; 4. Patients whose life expectancy is more than 3 months; 5. Patients with total metastasis <=5 and the largest tumor diameter <=6cm; 6. Patients who received first-line treatment for metastatic renal cancer for 3 months or more; according to the recist-1.1 evaluation standard, PR, Cr or SD curative effect has been obtained before oligoprogression; 7. Oligo progressive lesions should meet the following conditions: < 3 progressive lesions, and progressive lesions can meet any of the following conditions: new metastatic lesions appear, which can be evaluated according to the RECIST standard; compared with the best curative effect, the longest diameter of the original metastatic lesions increases by 20% and at least 5mm; 8. Safe SBRT can be obtained in all the oligometastases.

Exclusion criteria

Exclusion criteria: 1. Patients with radiotherapy contraindications; 2. Patients who have previously received radiotherapy at the site requiring SBRT treatment; 3. It is impossible to treat all patients with oligoprogressive lesions; 4. MRI images showed obvious compression of spinal cord and corresponding symptoms of nerve compression, and the patients needed emergency decompression; 5. Patients with liver and brain metastasis; 6. Patients who have received more than one-line systematic treatment for metastatic renal cancer in the past: targeted drug / immune / cytokine therapy; 7. Patients with other untreated malignant tumors.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
Local control;Time to next-line therapy;Overall survival;Toxicity;Quality of life;

Countries

China

Contacts

Public ContactLiru He

Sun Yat-sen University Cancer Center

helir@sysucc.org.cn+86 13631365597

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026