Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT06279351
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2023-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ETS', 'timeFrame': '8 weeks', 'description': 'Early tumor shrinkage'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '8 weeks'}, {'measure': 'DCR', 'timeFrame': '8 weeks'}, {'measure': 'PFS', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer']}, 'descriptionModule': {'briefSummary': '1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.\n2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;\n2. Physical state is good: PS 0-2;\n3. Expected survival of more than 3 months;\n4. Aged 18-75 years old;\n5. Have not received systematic chemotherapy before;\n6. Did not receive cetuximab treatment;\n7. Liver, kidney and bone marrow functions are basically normal;\n8. The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks;\n9. Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with severe dysfunction of vital organs (heart, liver, kidney);\n2. Patients with other malignant tumors;\n3. Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);\n4. In the active phase of acute or chronic infectious diseases;\n5. People with a clear history of drug allergy or allergic constitution;\n6. Patients participating in other clinical trials;\n7. Other conditions in which the patient was considered inappropriate to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06279351', 'briefTitle': 'Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Thalicolorectal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'Thalidomide+cetuximab+FOLFOX/FOLFIRI', 'interventionNames': ['Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'cetuximab+FOLFOX/FOLFIRI'}], 'interventions': [{'name': 'Thalidomide+cetuximab+FOLFOX/FOLFIRI', 'type': 'DRUG', 'description': 'Thalidomide+cetuximab+FOLFOX/FOLFIRI', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianguo Sun, Phd', 'role': 'CONTACT', 'email': 'sunjg09@aliyun.com', 'phone': '023-68774490'}], 'facility': 'the second affiliated hospital of Army medical university', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Jianguo Sun, doctor', 'role': 'CONTACT', 'email': 'sunjianguo@tmmu.edu.cn', 'phone': '023-68774490'}, {'name': 'rui kong, doctor', 'role': 'CONTACT', 'email': 'kongruiok@163.com', 'phone': '15823688918'}], 'overallOfficials': [{'name': 'rui kong, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chongqing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director of oncology department, Clinical Professor', 'investigatorFullName': 'Jianguo Sun', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}