Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:43 AM
Study NCT ID:
NCT07432594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is an open-label study; however, radiological assessments (for ORR/PFS) and pathological assessments (for pCR) will be performed by blinded independent reviewers who are unaware of the treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in tumor immune microenvironment (TiME) characteristics', 'timeFrame': 'At baseline, and at the time of surgery (up to 12 weeks)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Rate of R0 resection', 'timeFrame': 'At the time of surgery, up to 12 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Pathological complete response (pCR) rate', 'timeFrame': 'At the time of surgery, up to 12 weeks', 'description': 'Defined as the proportion of participants with no evidence of invasive cancer in the surgical specimens collected during interval debulking surgery (IDS).'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'From baseline up to approximately 2 years', 'description': '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.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'From baseline up to approximately 2 years', 'description': '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.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From randomization up to approximately 2 years', 'description': '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.'}, {'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': 'Through 28 days after the last dose of study drug, up to approximately 2 years', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant Chemotherapy', 'Interval Debulking Surgery', 'PD-1/CTLA-4 Bispecific Antibody', 'Aitua Combination Antibody', 'Nab-paclitaxel', 'Carboplatin', 'Immunotherapy'], 'conditions': ['High-grade Serous Ovarian Cancer (HGSOC)', 'Fallopian Tube Cancers', 'Primary Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nParticipants will be randomized in a 1:1 ratio into two groups:\n\nExperimental Group: Receives Nab-paclitaxel and Carboplatin combined with Aitua Combination Antibody.\n\nControl Group: Receives Nab-paclitaxel and Carboplatin alone.\n\nBoth 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.', 'detailedDescription': '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.\n\nInvestigational 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.\n\nChemotherapy 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.\n\nStudy 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.\n\nNeoadjuvant Phase: Patients receive 3 cycles of therapy (Q3W).\n\nSurgical 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).\n\nAdjuvant Phase: Post-surgery, patients will continue treatment with the assigned regimen for additional cycles.\n\nTranslational 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed high-grade serous ovarian cancer (HGSC), fallopian tube cancer, or primary peritoneal cancer.\n* International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Assessed by a multidisciplinary team (MDT) based on imaging (± laparoscopic exploration) as initially unable to achieve satisfactory tumor debulking (R0 resection).\n* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n* Major organ function is basically normal.\n* Willing to provide tumor tissue, peripheral blood, and ascites samples for translational research.\n\nExclusion Criteria:\n\n* Pathological types other than high-grade serous carcinoma (HGSC).\n* Prior receipt of any form of anti-tumor therapy.\n* History of autoimmune disease or requiring immunosuppressive therapy.\n* Known allergy to study drug components.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07432594', 'briefTitle': 'Neoadjuvant Aitua (PD-1/CTLA-4 Bispecific) Plus Nab-Paclitaxel and Carboplatin for Advanced High-Grade Serous Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2025-I2M-C&T-B-065'}}, 'armsInterventionsModule': {'armGroups': [{'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)', 'Procedure: Interval Debulking Surgery']}], 'interventions': [{'name': 'Aitua Combination Antibody', 'type': 'DRUG', 'otherNames': ['PD-1/CTLA-4 Bispecific Antibody', 'QL1706'], 'description': 'Administered via intravenous infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.', 'armGroupLabels': ['Nab-Paclitaxel + Carboplatin + Aitua Combo Ab']}, {'name': 'Albumin-Bound Paclitaxel /nab-Paclitaxel', 'type': 'DRUG', 'description': 'Administered via intravenous infusion at a dose of 260 mg/m\\^2 on Day 1 of each 3-week cycle.', 'armGroupLabels': ['Nab-Paclitaxel + Carboplatin', 'Nab-Paclitaxel + Carboplatin + Aitua Combo Ab']}, {'name': 'Carboplatin (AUC 5)', 'type': 'DRUG', 'description': 'Administered via intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.', 'armGroupLabels': ['Nab-Paclitaxel + Carboplatin', 'Nab-Paclitaxel + Carboplatin + Aitua Combo Ab']}, {'name': 'Interval Debulking Surgery', 'type': 'PROCEDURE', 'description': 'Performed after 3 cycles of neoadjuvant therapy. The goal is to achieve R0 resection (no macroscopic residual disease).', 'armGroupLabels': ['Nab-Paclitaxel + Carboplatin', 'Nab-Paclitaxel + Carboplatin + Aitua Combo Ab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ning Li, MD', 'role': 'CONTACT', 'email': 'liningnci@126.com', 'phone': '8610-87787211'}], 'overallOfficials': [{'name': 'Ning Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to institutional privacy regulations and patient confidentiality, individual participant data (IPD) will not be shared publicly.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'NING LI-GYN', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}