Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817214
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-04-05
Brief Title:
Cadonilimab Plus Anlotinib for RMP Cervical Cancer
Sponsor:
Zhongnan Hospital
Organization:
Zhongnan Hospital
Study Overview
Official Title:
Cadonilimab Plus Anlotinib for Recurrent Metastasis or Persistent Cervical Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
The goal of this clinical trial is to test a new treatment combination including cadonilimab anlotinib and granulocyte-macrophage colony-stimulating factor GM-CSF in recurrent metastasis and persistent cervical cancer The main questions it aims to answer are
The efficacy of this combination in RMP CC
The tolerance of this combination in RMP CC
Possible biomarker of treatment response for this combination
Participants will receive cadonilimab of 10mgkg every three weeks at day 1 take anlotinib 12mg orally in day 1 to day 14 then take a 7 days break and subcutaneously injection of GM-CSF 200ug from day 1 to day 14 then also take a 7-days break This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years
The efficacy of this combination in RMP CC
The tolerance of this combination in RMP CC
Possible biomarker of treatment response for this combination
Participants will receive cadonilimab of 10mgkg every three weeks at day 1 take anlotinib 12mg orally in day 1 to day 14 then take a 7 days break and subcutaneously injection of GM-CSF 200ug from day 1 to day 14 then also take a 7-days break This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years
Detailed Description:
The prognosis was poor for recurrent metastasis and persistent cervical cancer especially for those who had multiple lesions and history of previous radiation therapy KEYNOTE-826 Study demonstrated survival benefit of adding pembrolizumab into the standard first-line treatment for cervical cancer Here we designed a exploratory clinical study to test a new treatment combination including cadonilimab and anlotinib in recurrent metastasis and persistent cervical cancer All participants will receive cadonilimab of 10mgkg every three weeks at day 1 take anlotinib 8mg orally in day 1 to day 14 then take a 7-days break and subcutaneously injection of GM-CSF 200ug from day 1 to day 14 then also take a 7-days break This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years
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