Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455046
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer
Sponsor:
Fujian Cancer Hospital
Organization:
Fujian Cancer Hospital
Study Overview
Official Title:
Efficacy and Safety of AK104 Combined With Pemetrexed Carboplatin and Recombinant Human Adenovirus 5 Injection in Advanced Recurrent Cervical Cancer a Multicenter Single-arm Prospective Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
In order to improve the clinical effect and find a new safe and effective treatment model for advanced recurrent cervical cancer this study explored the efficacy level safety of pemetrexed carboplatin recombinant human adenovirus type 5 and AK104 regimen in recurrent and refractory advanced cervical cancer For some patients with immune-resistant cervical cancer combination chemotherapy and oncolytic virus therapy can promote the transformation of cold tumors into hot tumors eliminate and then reverse the suppressor factors of immune resistance and break the dilemma of immunotherapy drug resistance which is a new method and strategy under immunotherapy drug resistance
Detailed Description:
The Combined Treatment Stage consists of AK104 at a dosage of 10 mgkg Pemetrexed at a dosage of 500mgm2 Cisplatin with an AUC of 4-6 mgmLmin and Human Adenovirus 5 Injection This treatment is administered every 3 weeks for a total of 4 cycles Upon enrollment the drugs are given in the following sequence on the first day of each combined treatment cycle local injection of Human Adenovirus 5 Injection d1-d5 intravenous infusion of AK104 d1 intravenous infusion of Pemetrexed d2 and intravenous infusion of Cisplatin d2 The Maintenance Treatment Stage involves single-drug AK104 at a dose of 10 mgkg every 3 weeks for a duration lasting up to two 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