Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455072
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-06
Brief Title:
Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer
Sponsor:
Fujian Cancer Hospital
Organization:
Fujian Cancer Hospital
Study Overview
Official Title:
Nituzumab Plus Serplulimab Combined With SBRT in Recurrent Advanced Cervical Cancer A Prospective Multicenter Single-arm Phase II Clinical Trial
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 recurrent advanced cervical cancer patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy However immune checkpoint inhibitors combination therapy has become a promising strategy for advanced cervical cancer Epidermal Growth Factor Receptor EGFR is overexpressed in cervical cancer cells Stereotactic radiotherapy SBRT can enhance the efficacy of immunotherapy
Detailed Description:
In recurrent advanced cervical cancer patients were prone to drug resistance who have relapsed within prior platinum-based chemotherapy However immune checkpoint inhibitors combination therapy has become a promising strategy for advanced cervical cancer Epidermal Growth Factor Receptor EGFR is overexpressed in cervical cancer cells Stereotactic radiotherapy SBRT can enhance the efficacy of immunotherapy
Nituzumab is a humanized monoclonal antibody that binds to the epidermal growth factor receptor Serplulimab is a fully humanized high-affinity monoclonal antibody against programmed cell death-1 PD-1
This phase II single-arm study aims to evaluate the efficacy and safety of Nituzumab plus Serplulimab combined with SBRT in patients with recurrent advanced cervical cancer
Patients who have failed in standard chemotherapyhistopathologically confirmed recurrent advanced squamous cell cervical carcinoma regardless of programmed cell death-Ligand 1 PD-L1 expression Patients who have achieved the response state or come to stably at least six months after immunotherapy were allowed There was at least one lesion for SBRT in addition to target lesions ECOG 0-1 were considered eligible for enrollment
Nituzumab was given intravenously 400mg qw 21 days per cycle and Serplulimab was administered intravenously 200mg once every 3 weeksThe dose was 30-50 Gy in three to five fractions and the number of lesions was no more than four by SBRT The treatment was continued until disease progression death or intolerant toxicity
The primary endpoint was objective response rate ORR and the secondary endpoints included disease control rate DCR progression free survival PFS overall survival OS and safety
Nituzumab is a humanized monoclonal antibody that binds to the epidermal growth factor receptor Serplulimab is a fully humanized high-affinity monoclonal antibody against programmed cell death-1 PD-1
This phase II single-arm study aims to evaluate the efficacy and safety of Nituzumab plus Serplulimab combined with SBRT in patients with recurrent advanced cervical cancer
Patients who have failed in standard chemotherapyhistopathologically confirmed recurrent advanced squamous cell cervical carcinoma regardless of programmed cell death-Ligand 1 PD-L1 expression Patients who have achieved the response state or come to stably at least six months after immunotherapy were allowed There was at least one lesion for SBRT in addition to target lesions ECOG 0-1 were considered eligible for enrollment
Nituzumab was given intravenously 400mg qw 21 days per cycle and Serplulimab was administered intravenously 200mg once every 3 weeksThe dose was 30-50 Gy in three to five fractions and the number of lesions was no more than four by SBRT The treatment was continued until disease progression death or intolerant toxicity
The primary endpoint was objective response rate ORR and the secondary endpoints included disease control rate DCR progression free survival PFS overall survival OS and safety
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