Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT07003620
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '3 months post-treatment'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of death from any cause), assessed up to 3 years'}, {'measure': 'progression-free survival', 'timeFrame': 'From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years'}, {'measure': 'incidence of treatment-related adverse events', 'timeFrame': 'From the initiation of treatment until 30 days after the last dose of neoadjuvant immunochemotherapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancers']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, Phase II clinical trial designed to evaluate the efficacy and safety of paclitaxel and carboplatin combined with PD-1/PD-L1 immune checkpoint inhibitors in the treatment of locally advanced cervical cancer. Using single-cell RNA sequencing (scRNA-seq), the study aims to investigate the molecular mechanisms underlying differential treatment responses and optimize personalized therapeutic strategies.\n\nEligibility Criteria:\n\nPatients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \\>4 cm will be enrolled. All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, an ECOG performance status of 0-1, and no prior treatment.\n\nOutcome Measures:\n\n* Primary endpoint: Objective response rate (ORR), assessing tumor regression.\n* Secondary endpoints:Overall survival (OS), progression-free survival (PFS), and incidence of treatment-related adverse events (graded by CTCAE criteria).\n* Exploratory endpoint:\\*\\* Impact of treatment on the tumor microenvironment and gene expression profiles.\n\nStudy Intervention:\n\nAll patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis.\n\nSample Size:\n\nThe study plans to enroll at least 34 eligible patients. Based on treatment response, patients will be categorized into high-response and low-response groups, with a minimum of 5 cases per group selected for scRNA-seq to ensure robust molecular mechanism analysis. The sample size calculation assumes a historical ORR of 65% and a target ORR of 85%.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \\>4 cm will be enrolled.\n* All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma.\n* ECOG performance status of 0-1.\n* no prior treatment.\n\nExclusion Criteria:\n\n* Patients with a history of other malignant tumors in the past.\n* Patients whose clinical data or treatment information is incomplete.\n* Patients with severe comorbidities or those who cannot complete follow-up.'}, 'identificationModule': {'nctId': 'NCT07003620', 'briefTitle': 'Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'SYSKY-2024-1115-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'interventionNames': ['Drug: Neoadjuvant immunochemotherapy']}], 'interventions': [{'name': 'Neoadjuvant immunochemotherapy', 'type': 'DRUG', 'description': 'All patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaiwu Lu', 'role': 'CONTACT', 'email': 'luhuaiwu@mail.sysu.edu.cn', 'phone': '18688395806'}], 'facility': 'Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Huaiwu Lu', 'role': 'CONTACT', 'email': 'luhuaiwu@mail.sysu.edu.cn', 'phone': '18688395806'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou', 'investigatorFullName': 'Lu Huaiwu', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}