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Multi-center clinical study of tirelizumab and axitinib combined with stereotactic radiotherapy SBRT in the treatment of oligometastatic advanced renal carcinoma

Multi-center clinical study of tirelizumab and axitinib combined with stereotactic radiotherapy SBRT in the treatment of oligometastatic advanced renal carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067043
Enrollment
Unknown
Registered
2022-12-26
Start date
2022-12-31
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Oligometastatic advanced renal carcinoma

Interventions

Group A:tirelizumab+axitinib
Group B :tirelizumab+axitinib+SBRT

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Orthotopic recurrence or distant metastasis of renal cancer, histologic confirmation of clear cell renal cell carcinoma; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; 4. The number of oligo metastases is less than or equal to 5, the lesion is detectable according to the RECIST 1.1 criteria; 5. Patients with an estimated survival time > 1 year; 6. SBRT can be performed safely for at least one oligo metastasis; 7. Patients who had received systemic therapy (ineffective) or not received systemic therapy (treatment-naive); 8. All patients gave informed consent and signed a written consent form, patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures indicated in the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients who had received anti–PD-1 therapy or anti–PD-L1 therapy; 2. Had contraindications for radiotherapy; 3. The lesion area has been treated with high-dose radiotherapy; 4. Had other uncured malignant tumors; 5. Patients with severe cardiovascular and cerebrovascular diseases, uncontrollable hypertension, diabetes, and renal failure; 6. Pregnant or lactating women; 7. Evidence of spinal cord compression, surgical fixation of bone injury is required to maintain stability. 8. Patients with brain metastasis; 9. Patients with autoimmune diseases requiring therapy in the past 2 years; 10. Those considered unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall survival;Time to local progression;Progression-free survival;Disease control rate;Security;

Countries

China

Contacts

Public ContactLin-Hui Wang

The First Affiliated Hospital of Naval Medical University

wanglinhuicz@163.com+86 13901635510

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 17, 2026