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 patient's recurrence.
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 paclitaxel/carboplatin 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
RC48, 2.5mg/kg, iv, Q3W Carboplatin, AUC 5, iv, D1, Q3W
Completed Resection Rate
Completed Resection Rate (CRR): Complete tumor resection is defined as the absence of gross residual intra-abdominal and pelvic lesions assessed by the investigator during interval debulking surgery after the patient has received neoadjuvant therapy. The CRR is the percentage of patients achieving complete tumor resection.
Time frame: 3-month
Pathologic complete response
percentage of patients who achieved complete response
Time frame: 3-month
Objective Response Rate (ORR)
Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 3 cycles, ie ORR=CR+PR
Time frame: 3-month
Progression Free Survival (PFS)
Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first
Time frame: 3-year
Adverse Event Rate
The Adverse Event Rate is defined as the percentage of patients who experience any Adverse Events (AE), Serious Adverse Events (sAE), and Treatment-Related Adverse Events (TEAEs) from the first day of treatment till 2 years after discontinuing the medication
Time frame: from the first day of treatment till 30 days after discontinuing the medication
Overall survival
OS is defined as the time from the study enrollment to death due to any cause.
Time frame: 5-year
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