Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574763
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer a Prospective Phase 2 Exploratory Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this phase II single arm prospective clinical study is to evaluate the efficacy and toxicity of RC48 plus carboplatin neoadjuvant therapy in HER2 expressed epithelial ovarian cancer patients The main questions it aims to answer are
The improvement of complete resection rate and pathological complete rate of this regimen
The delayed effect of treatment regimens on patients recurrence
The improvement of complete resection rate and pathological complete rate of this regimen
The delayed effect of treatment regimens on patients recurrence
Detailed Description:
The current standard treatment for newly diagnosed ovarian cancer involves a combination of surgery chemotherapy and adjuvant therapy Ovarian cancer surgery is challenging and has a high incidence of postoperative complications Many studies have explored the use of neoadjuvant therapy before surgery to shrink tumors and downstage the disease aiming to increase the proportion of operable patients and the rate of complete resection while also reducing surgical difficulty and associated risks Guidelines recommend that neoadjuvant chemotherapy for high-grade serous ovarian cancer should be consistent with the first-line chemotherapy regimen with paclitaxelcarboplatin every three weeks being the preferred regimen in clinical practice
However there are still unmet needs in neoadjuvant chemotherapy for ovarian cancer 1 The rate of pathologic complete response pCR after neoadjuvant chemotherapy is less than 10 yet achieving pCR significantly improves prognosis 2 Using the same regimen for neoadjuvant chemotherapy and postoperative chemotherapy may lead to the development of subsequent chemotherapy resistance thereby shortening the time before the patient develops platinum resistance 3 Neoadjuvant chemotherapy can have severe adverse reactions
RC48 Disitamab Vedotin is a human epidermal growth factor 2 HER2-directed antibody-drug conjugate with a novel humanized anti-HER2 antibody disitamab conjugated to monomethyl auristatin E MMAE via a cleavable linker This study used RC48 combined with carboplatin to explore the efficacy and toxic side effects of this regimen as neoadjuvant therapy in epithelial ovarian cancer patients
However there are still unmet needs in neoadjuvant chemotherapy for ovarian cancer 1 The rate of pathologic complete response pCR after neoadjuvant chemotherapy is less than 10 yet achieving pCR significantly improves prognosis 2 Using the same regimen for neoadjuvant chemotherapy and postoperative chemotherapy may lead to the development of subsequent chemotherapy resistance thereby shortening the time before the patient develops platinum resistance 3 Neoadjuvant chemotherapy can have severe adverse reactions
RC48 Disitamab Vedotin is a human epidermal growth factor 2 HER2-directed antibody-drug conjugate with a novel humanized anti-HER2 antibody disitamab conjugated to monomethyl auristatin E MMAE via a cleavable linker This study used RC48 combined with carboplatin to explore the efficacy and toxic side effects of this regimen as neoadjuvant therapy in epithelial ovarian cancer patients
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