NCT06574763

Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer

Neoadjuvant RC48 Plus Carboplatin for HER2-expressing Advanced Ovarian Cancer: a Prospective Phase 2 Exploratory Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 patient's 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 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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	RC48/Carboplatin	RC48, 2.5mg/kg, iv, Q3W Carboplatin, AUC 5, iv, D1, Q3W

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2024-08-28
• Last updated: 2024-08-28