Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-06 @ 11:59 PM
Study NCT ID:
NCT04854668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-01
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic 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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 748}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) assessed by IRC', 'timeFrame': 'Baseline up to 15 months', 'description': 'PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'Baseline up to 15 months', 'description': 'PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Baseline up to 20 months', 'description': 'OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.'}, {'measure': 'Objective Response Rate（ORR）', 'timeFrame': 'Baseline up to 15 months', 'description': 'Percentage of subjects achieving complete response (CR) and partial response (PR) .'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Baseline up to 15 months', 'description': 'Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Baseline up to 15 months', 'description': 'DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '36727222', 'type': 'DERIVED', 'citation': 'He J, Liu Y, Liu C, Hu H, Sun L, Xu D, Li J, Wang J, Chen X, Lin R, Jiang Y, Zhang Y, Zhang W, Cheng Y, Wu X, Fang M, Li E, Xu Y, Chen Y, Li J, Cui Y, Pan Z, Zhang S, Yuan Y, Ding K. A Randomized Phase III Study of Anlotinib Versus Bevacizumab in Combination With CAPEOX as First-Line Therapy for RAS/BRAF Wild-Type Metastatic Colorectal Cancer: A Clinical Trial Protocol. Technol Cancer Res Treat. 2023 Jan-Dec;22:15330338231152350. doi: 10.1177/15330338231152350.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, randomized, phase Ⅲ study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy≥ 3 months.\n\n 3\\. Histologically or cytologically confirmed unresectable metastatic colorectal cancer.\n\n 4\\. Has RAS/BRAF wild-type. 5. Has at least one measurable lesion. 6. Adequate organ function. 7.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.\n\nExclusion Criteria:\n\n* 1.Has dMMR/MSI-H. 2. Combined with the following diseases or medical history:\n\n 1. Previous or co-existing malignancies within 3 years except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors；\n 2. Has many factors that affect the oral administration of drugs；\n 3. Has Gastrointestinal bleeding or perforation within 4 weeks before the first dose；\n 4. Has active inflammatory bowel disease within 4 weeks before the first dose；\n 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage；\n 6. Patients whose adverse events (except hair loss) caused by previous treatment did not recover to ≤CTCAE 1 degree；\n 7. Has received major surgical procedure、biopsy or obvious traumatic injury within 28 days before the first dose；\n 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary of blood vessels is unclear；\n 9. Has any bleeding event or the level of bleeding events ≥ CTCAE 3；\n 10. Has unhealed wounds, ulcerative or fractures；\n 11. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism；\n 12. Has a history of psychotropic substance abuse and are unable to quit ；\n 13. Has any severe and / or uncontrolled disease； 3.Tumor related symptoms and treatment\n\n <!-- -->\n\n 1. Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose.\n 2. Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose.\n 3. Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs.\n 4. Has received systematic treatment for advanced colorectal cancer.\n 5. Has symptomatic brain metastases or control of symptoms \\< 2 month. 4.Has participated in other anticancer drug clinical trials within 4 weeks. 5.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.'}, 'identificationModule': {'nctId': 'NCT04854668', 'briefTitle': 'A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'ALTN-Ⅲ-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib + CapeOx', 'description': 'Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine.', 'interventionNames': ['Drug: Anlotinib hydrochloride capsule', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab + CapeOx', 'description': 'Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine.', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Oxaliplatin', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Anlotinib hydrochloride capsule', 'type': 'DRUG', 'description': 'Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；', 'armGroupLabels': ['Anlotinib + CapeOx']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'Bevacizumab 7.5mg/kg, intravenous drip, on Day 1', 'armGroupLabels': ['Bevacizumab + CapeOx']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 130mg/m2, intravenous drip, on Day 1；', 'armGroupLabels': ['Anlotinib + CapeOx', 'Bevacizumab + CapeOx']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.', 'armGroupLabels': ['Anlotinib + CapeOx', 'Bevacizumab + CapeOx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '247000', 'city': 'Chizhou', 'state': 'Anhui', 'country': 'China', 'facility': "The People's Hospital of Chizhou", 'geoPoint': {'lat': 30.66134, 'lon': 117.47783}}, {'zip': '350011', 'city': 'Fuzhou', 'state': 'Anhui', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 29.99828, 'lon': 118.24016}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Cancer Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '242000', 'city': 'Xuancheng', 'state': 'Anhui', 'country': 'China', 'facility': "Xuancheng People's Hospital", 'geoPoint': {'lat': 30.9525, 'lon': 118.75528}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Frist Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '408099', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Fuling Hospital Affiliated to Chongqing University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350011', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 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