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.
Parallel
Aitua Combination Antibody
DrugAdministered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
Albumin-Bound Paclitaxel /nab-Paclitaxel
DrugAdministered via intravenous infusion at a dose of 260 mg/m\^2 on Day 1 of each 3-week cycle.
Carboplatin (AUC 5)
DrugAdministered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.
Interval Debulking Surgery
Procedure/SurgeryPerformed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).
Rate of R0 resection
Defined as the percentage of participants achieving optimal debulking surgery with no macroscopic residual disease (R0) after neoadjuvant therapy. This is assessed by the surgeon at the time of interval debulking surgery (IDS).
Pathological complete response (pCR) rate
Defined as the proportion of participants with no evidence of invasive cancer in the surgical specimens collected during interval debulking surgery (IDS).
Objective response rate (ORR)
Defined as the percentage of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, based on independent radiological review.
Disease control rate (DCR)
Defined as the percentage of participants who achieve a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Progression-free survival (PFS)
Defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first.
Change in tumor immune microenvironment (TiME) characteristics
Exploratory analysis of immune cell subsets, such as cluster of differentiation 8 positive (CD8+) T cells, regulatory T cells (Tregs), myeloid-derived suppressor cells (MDSCs), and tumor-associated macrophages (TAMs), in tumor tissue and peripheral blood. This uses single-cell RNA sequencing (scRNA-seq), multiplex immunohistochemistry/immunofluorescence (mIHC/mIF), and flow cytometry to evaluate the immunomodulatory effects of the treatment.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator
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