High-grade Serous Ovarian Cancer (HGSOC)Phase 2NCT07432594
Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
A Phase 2 study testing Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel and Carboplatin (AUC 5) in people with High-grade Serous Ovarian Cancer (HGSOC) and Fallopian Tube Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-grade Serous Ovarian Cancer (HGSOC), Fallopian Tube Cancers, Primary Peritoneal Cancer
- What is being tested?
- Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel and Carboplatin (AUC 5)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD, 8610-87787210, cancergcp@163.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Background and Rationale: Ovarian cancer has the highest mortality rate among gynecological malignancies, with High-Grade Serous Carcinoma (HGSC) being the most common subtype. HGSC is characterized by a highly immunosuppressive Tumor Immune Microenvironment (TiME), often referred to as an "immune desert," which limits the efficacy of single-agent immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 pathway.
Investigational Agent: Aitua Combination Antibody (QL1706) is a novel bifunctional antibody targeting both PD-1 and CTLA-4. Dual blockade of these pathways may synergistically activate anti-tumor immune responses: CTLA-4 inhibition promotes early T-cell activation in lymph nodes, while PD-1 inhibition reverses T-cell exhaustion within the tumor microenvironment. Previous studies in cervical cancer have shown that this bispecific antibody may offer improved efficacy with a manageable toxicity profile compared to combining two separate antibodies.
Chemotherapy Synergy: Albumin-bound paclitaxel (Nab-paclitaxel), a standard component of ovarian cancer treatment, avoids the need for corticosteroid pretreatment and has been shown to potentially enhance immune cell infiltration and regulate macrophage polarization. This study hypothesizes that combining Nab-paclitaxel/Carboplatin with the PD-1/CTLA-4 bispecific antibody will remodel the immune microenvironment and improve surgical outcomes.
Study Design: This is a single-center, open-label (with blinded assessment), randomized Phase II trial. Approximately 82 eligible patients will be stratified by FIGO stage (IIIC vs. IV) and randomized 1:1 to the experimental or control arm.
Neoadjuvant Phase: Patients receive 3 cycles of therapy (Q3W).
Surgical Phase: Patients with responsive or stable disease will undergo Interval Debulking Surgery (IDS). The primary endpoint is the R0 resection rate (no macroscopic residual disease).
Adjuvant Phase: Post-surgery, patients will continue treatment with the assigned regimen for additional cycles.
Translational Research: Tumor tissue, ascites, and peripheral blood will be collected at baseline, pre-surgery, and during therapy to analyze changes in immune cell subsets (e.g., via scRNA-seq, mIHC/mIF) and identify potential predictive biomarkers.
- Conditions
- High-grade Serous Ovarian Cancer (HGSOC), Fallopian Tube Cancers, Primary Peritoneal Cancer
- Being tested
- Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel, Carboplatin (AUC 5), Interval Debulking Surgery
- Keywords
- Neoadjuvant Chemotherapy, Interval Debulking Surgery, PD-1/CTLA-4 Bispecific Antibody, Aitua Combination Antibody, Nab-paclitaxel, Carboplatin, Immunotherapy
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aitua Combination AntibodyDrug
Also called PD-1/CTLA-4 Bispecific Antibody, QL1706
Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
Albumin-Bound Paclitaxel /nab-PaclitaxelDrug
Administered via intravenous infusion at a dose of 260 mg/m^2 on Day 1 of each 3-week cycle.
Carboplatin (AUC 5)Drug
Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.
Interval Debulking SurgeryProcedure or surgery
Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).
| Study group | Role | What they receive |
|---|---|---|
| Nab-Paclitaxel + Carboplatin + Aitua Combo Ab | Experimental | 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). Receives: Drug: Aitua Combination Antibody; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Carboplatin (AUC 5); Procedure: Interval Debulking Surgery |
| Nab-Paclitaxel + Carboplatin | Active comparator | 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). Receives: Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Drug: Carboplatin (AUC 5); Procedure: Interval Debulking Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of R0 resection
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).
Measured: At the time of surgery, up to 12 weeks
Secondary outcomes (7)
Pathological complete response (pCR) rate
Defined as the proportion of participants with no evidence of invasive cancer in the surgical specimens collected during interval debulking surgery (IDS).
Measured: At the time of surgery, up to 12 weeks
Objective response rate (ORR)
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.
Measured: From baseline up to approximately 2 years
Disease control rate (DCR)
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.
Measured: From baseline up to approximately 2 years
Progression-free survival (PFS)
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.
Measured: From randomization up to approximately 2 years
Incidence and severity of adverse events (AEs)
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).
Measured: Through 28 days after the last dose of study drug, up to approximately 2 years
Change from baseline in EORTC QLQ-C30 quality-of-life scores
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.
Measured: 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).
Change from baseline in EORTC QLQ-OV28 domain scores
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start23 Jul 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Serous Ovarian Cancer (HGSOC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, open-label, controlled study. Eligible participants are stratified by FIGO stage (IIIC vs. IV) and randomized in a 1:1 ratio to receive either the experimental regimen or the control regimen.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, NING LI-GYN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning Li, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432594
- Sponsor's protocol ID
- 2025-I2M-C&T-B-065
- Status last verified
- Nov 2026
- First submitted
- 12 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to institutional privacy regulations and patient confidentiality, individual participant data (IPD) will not be shared publicly.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07432594
- Acronym / sponsor ID
- 2025-I2M-C&T-B-065
- Conditions
- High-grade Serous Ovarian Cancer (HGSOC), Fallopian Tube Cancers, Primary Peritoneal Cancer
- Keywords
- Neoadjuvant Chemotherapy, Interval Debulking Surgery, PD-1/CTLA-4 Bispecific Antibody, Aitua Combination Antibody, Nab-paclitaxel, Carboplatin, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale: Ovarian cancer has the highest mortality rate among gynecological malignancies, with High-Grade Serous Carcinoma (HGSC) being the most common subtype. HGSC is characterized by a highly immunosuppressive Tumor Immune Microenvironment (TiME), often referred to as an "immune desert," which limits the efficacy of single-agent immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 pathway.
Investigational Agent: Aitua Combination Antibody (QL1706) is a novel bifunctional antibody targeting both PD-1 and CTLA-4. Dual blockade of these pathways may synergistically activate anti-tumor immune responses: CTLA-4 inhibition promotes early T-cell activation in lymph nodes, while PD-1 inhibition reverses T-cell exhaustion within the tumor microenvironment. Previous studies in cervical cancer have shown that this bispecific antibody may offer improved efficacy with a manageable toxicity profile compared to combining two separate antibodies.
Chemotherapy Synergy: Albumin-bound paclitaxel (Nab-paclitaxel), a standard component of ovarian cancer treatment, avoids the need for corticosteroid pretreatment and has been shown to potentially enhance immune cell infiltration and regulate macrophage polarization. This study hypothesizes that combining Nab-paclitaxel/Carboplatin with the PD-1/CTLA-4 bispecific antibody will remodel the immune microenvironment and improve surgical outcomes.
Study Design: This is a single-center, open-label (with blinded assessment), randomized Phase II trial. Approximately 82 eligible patients will be stratified by FIGO stage (IIIC vs. IV) and randomized 1:1 to the experimental or control arm.
Neoadjuvant Phase: Patients receive 3 cycles of therapy (Q3W).
Surgical Phase: Patients with responsive or stable disease will undergo Interval Debulking Surgery (IDS). The primary endpoint is the R0 resection rate (no macroscopic residual disease).
Adjuvant Phase: Post-surgery, patients will continue treatment with the assigned regimen for additional cycles.
Translational Research: Tumor tissue, ascites, and peripheral blood will be collected at baseline, pre-surgery, and during therapy to analyze changes in immune cell subsets (e.g., via scRNA-seq, mIHC/mIF) and identify potential predictive biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, open-label, controlled study. Eligible participants are stratified by FIGO stage (IIIC vs. IV) and randomized in a 1:1 ratio to receive either the experimental regimen or the control regimen.
| Arm | Type | Receives |
|---|---|---|
| Nab-Paclitaxel + Carboplatin + Aitua Combo Ab | Experimental | Drug: Aitua Combination Antibody, Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel, Drug: Carboplatin (AUC 5), Procedure: Interval Debulking SurgeryParticipants 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). |
| Nab-Paclitaxel + Carboplatin | Active comparator | Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel, Drug: Carboplatin (AUC 5), Procedure: Interval Debulking SurgeryParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aitua Combination AntibodyAlso: PD-1/CTLA-4 Bispecific Antibody, QL1706Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle. | Drug | Nab-Paclitaxel + Carboplatin + Aitua Combo Ab |
| Albumin-Bound Paclitaxel /nab-PaclitaxelAdministered via intravenous infusion at a dose of 260 mg/m^2 on Day 1 of each 3-week cycle. | Drug | Nab-Paclitaxel + Carboplatin, Nab-Paclitaxel + Carboplatin + Aitua Combo Ab |
| Carboplatin (AUC 5)Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. | Drug | Nab-Paclitaxel + Carboplatin, Nab-Paclitaxel + Carboplatin + Aitua Combo Ab |
| Interval Debulking SurgeryPerformed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease). | Procedure or surgery | Nab-Paclitaxel + Carboplatin, Nab-Paclitaxel + Carboplatin + Aitua Combo Ab |
Primary outcome
Rate of R0 resection
Time frame: 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).
7 secondary outcomes
Pathological complete response (pCR) rate
Time frame: At the time of surgery, up to 12 weeks
Objective response rate (ORR)
Time frame: From baseline up to approximately 2 years
Disease control rate (DCR)
Time frame: From baseline up to approximately 2 years
Progression-free survival (PFS)
Time frame: From randomization up to approximately 2 years
Incidence and severity of adverse events (AEs)
Time frame: Through 28 days after the last dose of study drug, up to approximately 2 years
Change from baseline in EORTC QLQ-C30 quality-of-life scores
Time frame: 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).
Change from baseline in EORTC QLQ-OV28 domain scores
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Due to institutional privacy regulations and patient confidentiality, individual participant data (IPD) will not be shared publicly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aitua Combination Antibody, Albumin-Bound Paclitaxel /nab-Paclitaxel and Carboplatin (AUC 5) in people with High-grade Serous Ovarian Cancer (HGSOC) and Fallopian Tube Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, MD (8610-87787211, liningnci@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of R0 resection (time frame: At the time of surgery, up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.