Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587817
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-09-15
Brief Title:
Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
An Observational Single-center Study of Radiotherapy Combined With Immunotherapy for Massive Tumors
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 camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer soft tissue sarcoma or urothelial carcinoma Hypofractionation which represented by stereotactic body radiation therapy SBRT is a technique that delivers higher daily doses of radiation over a shorter period of time This trial will also observe the index which can influencing the curative effect of hyperfractionated radiotherapy combined with immunotherapy
Detailed Description:
This trial is a prospective observational single-center single-arm clinical research This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer soft tissue sarcoma or urothelial carcinoma All enrolled patients will receive the following treatments camrelizumab 200mg every 2 weeks until disease progression as determined by RECIST 11 intolerance or patientphysician decision to stop treatment One week following completion of the first immunotherapy hypofractionated radiotherapySABR with tumor center dose of 24-32Gy8Gy3-4f and surrounding important organs at risk 30Gy will be performed And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin Generally the radiotherapy will end before the fourth 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 60 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 60 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