Aitua plus Nab-Paclitaxel and Carboplatin before surgery for advanced high-grade serous ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, randomized, open-label study conducted at a single center to see if adding Aitua Combination Antibody to Nab-paclitaxel and carboplatin improves the rate of R0 resection in patients with stage IIIC-IV HGSC, fallopian tube cancer, or primary peritoneal cancer. Participants receive 3 cycles of neoadjuvant therapy, followed by interval debulking surgery, with primary comparison on R0 resection rates between the antibody-containing and control arms. Secondary considerations include the immunologic effects of dual PD-1/CTLA-4 blockade in the tumor microenvironment and potential safety signals. The trial builds on the premise that remodeling the immune milieu can enhance surgical outcomes in HGSC. The study is designed as a single-center, open-label trial with blinded assessment of surgical endpoints.

Why it matters

Who can join: the full rules

Inclusion 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.
* Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
* Major organ function is basically normal.
* Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.

Exclusion Criteria:

* 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.
* Pregnant or lactating women.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Ning Li, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Ning Li, MD
• Email: liningnci@126.com
• Phone: 8610-87787211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.