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Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2026-03-01
Completion Date
2027-06-30
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
Aitua Combination Antibody
Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
Albumin-Bound Paclitaxel /nab-Paclitaxel
Administered via intravenous infusion at a dose of 260 mg/m\^2 on Day 1 of each 3-week cycle.
Carboplatin (AUC 5)
Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.
Interval Debulking Surgery
Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).