Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07248956
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059248', 'term': 'Chemoradiotherapy'}], '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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival (EFS)', 'timeFrame': '2 years', 'description': 'Duration from treatment initiation until the first occurrence of any of the following events: disease progression precluding surgical intervention, local or distant recurrence, death from any cause, etc.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date.'}, {'measure': 'Locoregional Control Rate (LRFS)', 'timeFrame': '2 years', 'description': 'Duration from the date of tumor treatment initiation to the date of first documented locoregional recurrence, death from any cause, or the last follow-up date.'}, {'measure': 'Laryngeal Preservation Rate', 'timeFrame': '2 years', 'description': 'The proportion of patients who successfully retain laryngx function after treatment.'}, {'measure': 'Major Pathological Response Rate (MPR)', 'timeFrame': '2 years', 'description': 'The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes.'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'Acute treatment-related toxicities were evaluated using CTCAE v5.0 (Common Terminology Criteria for Adverse Events, Version 5.0), with patient counts reported for each AE category.\n\nLate radiation toxicities were assessed per the RTOG (Radiation Therapy Oncology Group) grading criteria, with both patient numbers and incidence rates documented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-1 inhibitor', 'neoadjuvant therapy', 'locally advanced'], 'conditions': ['Hypopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized controlled, prospective clinical study.', 'detailedDescription': 'The early symptoms of hypopharyngeal cancer are often inconspicuous, with approximately 70% of patients clinically diagnosed at an advanced stage. With the emergence of immunotherapy, immune therapies such as PD-1 inhibitors combined with induction chemotherapy have been widely explored in various tumor types. Currently, there is a lack of large-scale real-world studies on the efficacy and safety of treatment options for patients with locally advanced hypopharyngeal cancer who respond well to neoadjuvant therapy. This study aims to employ neoadjuvant chemotherapy combined with immunotherapy for locally advanced hypopharyngeal cancer and explore the effectiveness and safety of different subsequent treatment options for patients assessed as achieving a major partial response (PR ≥50%).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willingness to provide written informed consent;\n2. Age ≥18 and ≤75 years;\n3. Treatment-naïve for malignant disease;\n4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;\n5. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding status;\n2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;\n3. Poorly controlled cardiovascular conditions or other diseases;\n4. Active or documented history of autoimmune diseases requiring systemic treatment;\n5. Synchronous or metachronous malignancies;\n6. Other conditions deemed ineligible for the study by investigators.'}, 'identificationModule': {'nctId': 'NCT07248956', 'briefTitle': 'Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Eye & ENT Hospital of Fudan University'}, 'officialTitle': 'Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'SOAR-HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neoadjuvant therapy followed by surgery and (C)RT group', 'description': 'Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.', 'interventionNames': ['Drug: Finolizumab', 'Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel', 'Drug: Cisplatin', 'Procedure: Surgery with postoperative radiotherapy or chemoradiotherapy.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'neoadjuvant therapy followed by CCRT group', 'description': 'Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.', 'interventionNames': ['Drug: Finolizumab', 'Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel', 'Drug: Cisplatin', 'Radiation: Definitive radiotherapy']}], 'interventions': [{'name': 'Finolizumab', 'type': 'DRUG', 'description': '200mg every 3 weeks (q3w) for 2 cycles.', 'armGroupLabels': ['neoadjuvant therapy followed by CCRT group', 'neoadjuvant therapy followed by surgery and (C)RT group']}, {'name': 'Albumin-Bound Paclitaxel /nab-Paclitaxel', 'type': 'DRUG', 'description': '260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.', 'armGroupLabels': ['neoadjuvant therapy followed by CCRT group', 'neoadjuvant therapy followed by surgery and (C)RT group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.', 'armGroupLabels': ['neoadjuvant therapy followed by CCRT group', 'neoadjuvant therapy followed by surgery and (C)RT group']}, {'name': 'Definitive radiotherapy', 'type': 'RADIATION', 'description': 'Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)', 'armGroupLabels': ['neoadjuvant therapy followed by CCRT group']}, {'name': 'Surgery with postoperative radiotherapy or chemoradiotherapy.', 'type': 'PROCEDURE', 'description': 'surgery with postoperative radiotherapy or chemoradiotherapy.', 'armGroupLabels': ['neoadjuvant therapy followed by surgery and (C)RT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Susheng Miao, PhD', 'role': 'CONTACT', 'email': 'drmiaosusheng@126.com', 'phone': '8613796620079'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenghua Lv, PhD', 'role': 'CONTACT', 'email': 'entlvzhenghua@163.com', 'phone': '8615168889970'}], 'facility': 'Shandong Provincial ENT Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhong, PhD', 'role': 'CONTACT', 'email': 'zhongqi_ent@126.com', 'phone': '8613520298736'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changming An, PhD', 'role': 'CONTACT', 'email': 'mran1979@163.com', 'phone': '8613811381160'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Zhang, PhD', 'role': 'CONTACT', 'email': 'zmzlm@163.com', 'phone': '8621-64377151'}], 'facility': 'Eye & ENT Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinsheng Huang, PhD', 'role': 'CONTACT', 'email': 'huang.xinsheng@zs-hospital.sh.cn', 'phone': '8613681791739'}], 'facility': 'Zhongshan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuan Zhou, PhD', 'role': 'CONTACT', 'email': 'xuanzhou@tmu.edu.cn', 'phone': '8618622682591'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Chiyao Hsueh', 'role': 'CONTACT', 'email': 'hsuehchiyao@gmail.com', 'phone': '021-64377134'}], 'overallOfficials': [{'name': 'Ming Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye & ENT Hospital, Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eye & ENT Hospital of Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ming Zhang', 'investigatorAffiliation': 'Eye & ENT Hospital of Fudan University'}}}}