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.
Age ≥ 18 years.
Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.
International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Pathological types other than high-grade serous carcinoma (HGSC).
Prior receipt of any form of anti-tumor therapy.
History of autoimmune disease or requiring immunosuppressive therapy.
Known allergy to study drug components.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator