At a glance
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A Prospective, Randomized, Controlled Phase II Clinical Study of Albumin-Bound Paclitaxel/Carboplatin Combined With Aitua Combination Antibody (PD-1/CTLA-4 Bispecific Antibody) for the Neoadjuvant Treatment of Advanced High-Grade Serous Ovarian Cancer With Unsatisfactory Debulking
In Brief
A Phase 2 clinical trial evaluating Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel, and 2 other interventions for High-grade Serous Ovarian Cancer (HGSOC) and 2 related conditions. Not yet recruiting, targeting 82 participants.
Detailed Summary
This is a prospective, randomized, controlled Phase II clinical study designed to evaluate the efficacy and safety of adding Aitua Combination Antibody (a PD-1/CTLA-4 bispecific antibody) to standard neoadjuvant chemotherapy for patients with advanced high-grade serous ovarian cancer. The study focuses on patients who are newly diagnosed with Stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer and are assessed as unable to achieve satisfactory tumor debulking (R0 resection) initially. Participants will be randomized in a 1:1 ratio into two groups: Experimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody. Control Group: Receives Nab-paclitaxel and Carboplatin alone. Both groups will receive 3 cycles of neoadjuvant treatment followed by Interval Debulking Surgery (IDS). The primary goal is to compare the R0 resection rate (complete removal of macroscopic tumor) between the two groups during surgery. Secondary goals include assessing pathological complete response (pCR), objective response rate, progression-free survival, and safety. The study also aims to explore how this combination therapy affects the tumor immune microenvironment.
Study Details
Timeline
Interventions
Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
Administered via intravenous infusion at a dose of 260 mg/m\^2 on Day 1 of each 3-week cycle.
Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.
Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).