NCT07432594RecruitingPhase 2
Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 23 Jul 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Ovarian cancer
- NCT number
- NCT07432594
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 82
- From 23 Jul 2026 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior receipt of any form of anti-tumor therapy.
Other illness
- History of autoimmune disease or requiring immunosuppressive therapy.
- Known allergy to study drug components.
Other
- Pathological types other than high-grade serous carcinoma (HGSC).
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.