Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558682
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Neoadjuvant Therapy in Cervical Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Disitamab Vedotin Combined with Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer a Prospective Single-arm Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China 498 of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer While paclitaxel combined with cisplatin is the conventional approach 98 to 306 of patients demonstrate suboptimal responses with a pathological complete response rate of approximately 10
Currently the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expressionThe study will assess the impact of this regimen on pathological complete response rates surgical complications surgical resection rates and overall survival
Currently the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expressionThe study will assess the impact of this regimen on pathological complete response rates surgical complications surgical resection rates and overall survival
Detailed Description:
Primary research objectives
To evaluate the effect of Disitamab Vedotin combined with cisplatin on pathological response rate pCR of locally advanced cervical cancer
Secondary research objectives
1 To evaluate the safety of Disitamab Vedotin combined with cisplatin
2 To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications surgical clearance rate and postoperative adjuvant treatment ratio
3 To evaluate the effects of Disitamab Vedotin combined with cisplatin on objective tumor response rate ORR disease control rate DCR and survival
Exploratory research objectives
To explore the changes of tumor tissue protein expression immune factors and HER-2 receptor expression before and after the use of ADC drugs as well as biomarkers that can effectively predict the therapeutic effect
To evaluate the effect of Disitamab Vedotin combined with cisplatin on pathological response rate pCR of locally advanced cervical cancer
Secondary research objectives
1 To evaluate the safety of Disitamab Vedotin combined with cisplatin
2 To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications surgical clearance rate and postoperative adjuvant treatment ratio
3 To evaluate the effects of Disitamab Vedotin combined with cisplatin on objective tumor response rate ORR disease control rate DCR and survival
Exploratory research objectives
To explore the changes of tumor tissue protein expression immune factors and HER-2 receptor expression before and after the use of ADC drugs as well as biomarkers that can effectively predict the therapeutic effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None