Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer

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: Receive

Trial Details

NCT ID
NCT07432594
Phase
PHASE2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Status
RECRUITING
Cancer Type
High-Grade Serous Ovarian Cancer
Interventions
  • Aitua Combination Antibody
  • Albumin-Bound Paclitaxel /nab-Paclitaxel
  • Carboplatin (AUC 5)
  • Interval Debulking Surgery
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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