Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 4:08 AM
Study NCT ID:
NCT04110093
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2019-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2019-09-28', 'studyFirstSubmitQcDate': '2019-09-28', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months', 'description': 'Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.'}, {'measure': 'Progress Free Survival', 'timeFrame': 'Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months', 'description': 'Time from treatment beginning until disease progression'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months', 'description': 'Time from treatment beginning until death from any cause'}, {'measure': 'Adverse Effect', 'timeFrame': 'Through study completion, an average of 1 months', 'description': 'Incidence of Treatment-related adverse Events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Immunotherapy', 'Regorafenib', 'Nivoluamb', 'microsatellite stable'], 'conditions': ['Colorectal Cancer', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'This study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (MSS) colorectal cancer (CRC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced Colorectal Cancer diagnosed histologically;\n* Patients with microsatellite stable (MSS)\n* Patients have no any standard choice after multiple line of therapy( ≥ 2 lines);\n* Expected survival ≥ 3 month;\n* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \\<1.5 times the upper limit of normal (ULN); Liver ALT and AST \\<2.5 × ULN and if liver metastases, ALT and AST \\<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min\n\nExclusion Criteria:\n\n* Patient still has standard treatment therapy based on NCCN guidance;\n* Patient can not comply with research program requirements or follow-up;'}, 'identificationModule': {'nctId': 'NCT04110093', 'briefTitle': 'Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'The Efficacy and Safety of Regorafenib Plus PD-1 Inhibitor as Third-line Therapy in Advanced Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'CZ-REGONIVO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunotherapy Combination treatment', 'description': 'All colorectal cancer patients received regorafenib plus PD-1 inhibitor', 'interventionNames': ['Drug: Regorafenib and PD-1 inhibitor']}], 'interventions': [{'name': 'Regorafenib and PD-1 inhibitor', 'type': 'DRUG', 'description': 'All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).', 'armGroupLabels': ['Immunotherapy Combination treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhan Wang', 'role': 'CONTACT', 'email': '13916229609@139.com', 'phone': '+86-13916229609'}, {'name': 'Yuan-Sheng Zang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Medical Oncology, Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Medical Oncology Department', 'investigatorFullName': 'Yuan-Sheng Zang', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}