Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333821
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2023-02-09
Brief Title:
A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma
Sponsor:
Biotech Pharmaceutical Co Ltd
Organization:
Biotech Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicentre Prospective Randomized Double-blind Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma
The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival
The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival
Detailed Description:
This is a multicenter prospective randomized double-blind placebo-controlled clinical studyThe trail will enroll 460 subjects FIGO 2018 stageIB3-IVAwho meet enrollment criteria but do not meet exclusion criteria According to clinical stage FIGO 2018 stage stage IB3-IIB or III-IVA tumor diameter 4cm or 4cm age 18 years and 65 years old or 65 years old and 80 years old for stratified randomization They are divided into experimental group and control group according to 11 Patients in the experimental group will receive nimotuzumab 400mg on the basis of concurrent chemoradiotherapy once a week for 7-8 weeks and then maintenance treatment once every 2 weeks for 24 weeks Using placeboNimotuzumab injection mimics in the control group 80 ml on the basis of concurrent chemoradiotherapy once a week for 7 to 8 weeks after the maintenance treatment once every 2 weeks for 24 weeks Patients with incomplete tumor response assessed by imaging and pathological examination 3 months after radiotherapy can be given 2-4 cycles of adjuvant chemotherapy with cisplatincarboplatin combined with paclitaxel regimen Regular imaging examination and survival follow-up were performed after treatment The primary efficacy end point was progression-free survival
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