Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609293
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-26
Brief Title:
Observational Study of Camrelizumab Combined With Apatinib and Hyperfractionated Radiotherapy for Renal Cell Carcinoma
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Observational Study of Camrelizumab Combined With Apatinib and Hyperfractionated Radiotherapy for Renal Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will explore effectiveness and safety using the combination therapy of camrelizumabapatinib and hyperfractionated radiotherapy in patients with renal cell carcinomaRCC Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of timeimmunotherapy hyperfractionated radiotherapy represented by stereotactic body radiation therapy SBRT can significantly improve the radiotherapy sensitivity of RCC This trial will also observe whether SBRT can bring about immune effects and explore the group and individual indicators that affect the treatment effect of RCC
Detailed Description:
This trial is a prospective single-center observational clinical trial evaluating the combination therapy of camrelizumabapatinib and hyperfractionated radiotherapy in patients with renal cell carcinomaRCC All enrolled patients will receive the following treatments camrelizumab 200mg every 2 weeks for 1 years combined with apatinib 250mg everyday until disease progression as determined by RECIST 11 intolerance or patientphysician decision to stop treatment One week following completion of the second immunotherapy hypofractionated radiotherapy with marginal dose of 50Gy2Gy25f and tumor center dose of local hyperfraction increase 24-32Gy8-12Gy3-4f will be performed 3-5 times The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy
During treatment participants will be assessed for curative effects and the occurrence of adverse events Following treatment participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information The planned sample size is 30 study participants
During treatment participants will be assessed for curative effects and the occurrence of adverse events Following treatment participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information The planned sample size is 30 study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None