Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| High-grade Serous Ovarian Cancer (HGSOC) | High-Grade Serous Ovarian Cancer | ONTOLOGY_EXACT | 0.85 |
| Primary Peritoneal Cancer | Fallopian Tube Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aitua Combination Antibody | Drug | — | UNRESOLVED |
| Albumin-Bound Paclitaxel /nab-Paclitaxel | Drug | — | UNRESOLVED |
| Carboplatin (AUC 5) | Drug | Carboplatin | ALIAS |
| Interval Debulking Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nab-Paclitaxel + Carboplatin + Aitua Combo Ab
- description
- Participants receive Nab-paclitaxel (260 mg/m\^2), Carboplatin (AUC 4-5), and Aitua Combination Antibody (5 mg/kg) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).
- interventionNames
- Drug: Aitua Combination Antibody
- Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
- Drug: Carboplatin (AUC 5)
- Procedure: Interval Debulking Surgery
- type
- ACTIVE_COMPARATOR
- label
- Nab-Paclitaxel + Carboplatin
- description
- Participants receive Nab-paclitaxel (260 mg/m\^2) and Carboplatin (AUC 4-5) intravenously on Day 1 of each 3-week cycle for 3 cycles as neoadjuvant therapy, followed by Interval Debulking Surgery (IDS).
- interventionNames
- Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
- Drug: Carboplatin (AUC 5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available