Trial · NCT07432594
Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
NCT07432594, Phase 2, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer. Trials, record NCT07432594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07432594
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
- NCT number
- NCT07432594
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 82 participants, estimated
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Conditions
- High-grade Serous Ovarian Cancer (HGSOC), Fallopian Tube Cancers, Primary Peritoneal Cancer
- Interventions
- Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel, Carboplatin (AUC 5), Interval Debulking Surgery
- First posted
- 2026-02-25
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of R0 resection | At the time of surgery, up to 12 weeks | Defined as the percentage of participants achieving optimal debulking surgery with no macroscopic residual disease (R0) after neoadjuvant therapy. This is assessed by the surgeon at the time of interval debulking surgery (IDS). |
| Secondary | Pathological complete response (pCR) rate | At the time of surgery, up to 12 weeks | Defined as the proportion of participants with no evidence of invasive cancer in the surgical specimens collected during interval debulking surgery (IDS). |
| Secondary | Objective response rate (ORR) | From baseline up to approximately 2 years | Defined as the percentage of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, based on independent radiological review. |
| Secondary | Disease control rate (DCR) | From baseline up to approximately 2 years | Defined as the percentage of participants who achieve a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Secondary | Progression-free survival (PFS) | From randomization up to approximately 2 years | Defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause, whichever occurs first. |
| Secondary | Incidence and severity of adverse events (AEs) | Through 28 days after the last dose of study drug, up to approximately 2 years | Safety will be assessed by monitoring the frequency and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. This includes monitoring for immune-related adverse events (irAEs). |
| Secondary | Change from baseline in EORTC QLQ-C30 quality-of-life scores | Baseline (before dosing on Cycle 1 Day 1), before dosing on Day 1 of Cycles 2 and 3, and within 7 days before interval debulking surgery (up to approximately 12 weeks). | Patient-reported health-related quality of life will be assessed using the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Global health status/quality of life, functioning, and symptom scores will be calculated separately and transformed to a 0-100 scale according to the EORTC scoring manual. Higher global health status/quality of life and functioning scores indicate better outcomes, whereas higher symptom and financial difficulty scores indicate worse outcomes. Change from baseline will be assessed at each scheduled post-baseline visit. |
| Secondary | Change from baseline in EORTC QLQ-OV28 domain scores | Baseline (before dosing on Cycle 1 Day 1), before dosing on Day 1 of Cycles 2 and 3, and within 7 days before interval debulking surgery (up to approximately 12 weeks). | Patient-reported ovarian cancer-specific quality of life will be assessed using the 28-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (EORTC QLQ-OV28). The questionnaire assesses abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment, and sexual functioning. Domain scores will be calculated separately and transformed to a 0-100 scale. Higher symptom/problem scores indicate worse outcomes; sexual functioning scores will be oriented so that higher scores indicate better functioning. Change from baseline will be assessed at each scheduled post-baseline visit. |
| Other | Change in tumor immune microenvironment (TiME) characteristics | At baseline, and at the time of surgery (up to 12 weeks) | Exploratory analysis of immune cell subsets, such as cluster of differentiation 8 positive (CD8+) T cells, regulatory T cells (Tregs), myeloid-derived suppressor cells (MDSCs), and tumor-associated macrophages (TAMs), in tumor tissue and peripheral blood. This uses single-cell RNA sequencing (scRNA-seq), multiplex immunohistochemistry/immunofluorescence (mIHC/mIF), and flow cytometry to evaluate the immunomodulatory effects of the treatment. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07432594
GET https://conductscience.org/api/trials/v1/NCT07432594/registered