Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-26 @ 1:51 AM
Study NCT ID:
NCT05738694
Status:
RECRUITING
Last Update Posted:
2023-05-09
First Post:
2023-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077784', 'term': 'Axitinib'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D009392', 'term': 'Nephrectomy'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-06', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival (DFS)', 'timeFrame': '2 years', 'description': 'To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.'}], 'secondaryOutcomes': [{'measure': 'The cancer-specific survival (CSS)', 'timeFrame': '3 years', 'description': 'cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.'}, {'measure': 'overall survival (OS)', 'timeFrame': '3 years', 'description': 'overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause'}, {'measure': 'objective response rate (ORR)', 'timeFrame': '3 years', 'description': 'CR and PR rate as assessed by RECIST 1.1'}, {'measure': 'major pathological response (MPR)', 'timeFrame': '3 years', 'description': 'MPR (≤10% viable malignant cells per local pathology assessment)'}, {'measure': 'adverse event management', 'timeFrame': '3 years', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma', 'Neoadjuvant']}, 'descriptionModule': {'briefSummary': 'The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.', 'detailedDescription': 'Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females between 18 years old and 80 years old;\n2. Histopathologically confirmed clear cell carcinoma;\n3. Staged as T2G3-4 or T3-T4 or N1\n\nExclusion Criteria:\n\n1. With distant metastasis\n2. Severe liver and renal dysfunction, combined with other serious diseases;\n3. Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;\n4. Severe/unstable angina pectoris; uncontrolled hypertension;\n5. Class III or IV heart failure by New York Heart Association (NYHA) Functional Classification;\n6. Ventricular arrhythmia requiring drug treatment.'}, 'identificationModule': {'nctId': 'NCT05738694', 'briefTitle': 'Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '2021-FXY-518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neoadjuvant group', 'description': 'Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy', 'interventionNames': ['Drug: Axitinib plus Toripalimab', 'Procedure: nephrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The control group will be given nephrectomy alone.', 'interventionNames': ['Procedure: nephrectomy']}], 'interventions': [{'name': 'Axitinib plus Toripalimab', 'type': 'DRUG', 'otherNames': ['nephrectomy'], 'description': 'Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.', 'armGroupLabels': ['Neoadjuvant group']}, {'name': 'nephrectomy', 'type': 'PROCEDURE', 'description': 'nephrectomy', 'armGroupLabels': ['Control group', 'Neoadjuvant group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sujun Han, Dr', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhisong He, Dr', 'role': 'CONTACT'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiling Zhang, Dr', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'JUn Xiao, Dr', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailiang Zhang, Dr', 'role': 'CONTACT'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Zeng, Dr', 'role': 'CONTACT'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Xin, Dr', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuepei Zhang, Dr', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhengzhou Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhiling Zhang, Professor', 'role': 'CONTACT', 'email': 'zhangzhl@sysucc.org.cn', 'phone': '+86-020-87343860'}], 'overallOfficials': [{'name': 'Fangjian Zhou, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Dept. of Urology, Sun Yat-sen University Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZHOU FANGJIAN', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ZHOU FANGJIAN', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}