Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-01 @ 2:14 PM
Study NCT ID:
NCT07085169
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014271', 'term': 'Trifluridine'}, {'id': 'C000613754', 'term': 'tipiracil'}, {'id': 'C000613803', 'term': 'trifluridine tipiracil drug combination'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-month progression-free survival rate', 'timeFrame': '6 months', 'description': 'Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Objective response rate', 'timeFrame': 'up to 16 weeks'}, {'measure': 'Progression free survival', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months'}, {'measure': 'Overall survival', 'timeFrame': 'From date of enrollment until the date of death from any cause, assessed up to 100 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colo-rectal Cancer', 'Third-line and Beyond Therapy', 'TAS 102', 'Bevacizumab']}, 'descriptionModule': {'briefSummary': 'This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.', 'detailedDescription': 'The treatment options as third-line therapy for metastatic colorectal cancer patients are limited. Trifluridine/tipiracil (TAS-102) plus bevacizumab has been approved in colorectal cancer for patients who are refractory to or intolerant of standard chemotherapy. However, the toxicity of trifluridine/tipiracil at standard dose a clinical concerned issue. Modifications of dose and treatment cycle of trifluridine/tipiracil have been investigated, and show promising effect to reduce the toxicity. In this study, patients with refractory metastatic colorectal cancer who have disease progression after at least 2 standard regimens will be treated with low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age over 60 years old, male and female\n2. histologically confirmed adenocarcinoma of the colon or rectum\n3. patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen\n4. with or without measurable lesions\n5. ECOG 0 to 2, expected survival time over 3 months\n6. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.\n7. Signed informed consent and willing to follow the study protocol\n\nExclusion Criteria:\n\n1. symptomatic metastases of central nervous system\n2. other primary malignancies\n3. uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease\n4. organ functions that cannot tolerate study treatment\n5. bowel obstruction or other conditions affecting oral administration\n6. allergic to study medication\n7. other conditions that patients are unsuitable for this study assessed by the investigators'}, 'identificationModule': {'nctId': 'NCT07085169', 'briefTitle': 'Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study', 'orgStudyIdInfo': {'id': 'TAS-102/2025-No.412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Trifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w', 'interventionNames': ['Drug: Trifluridine/tipiracil (TAS-102) plus bevacizumab']}], 'interventions': [{'name': 'Trifluridine/tipiracil (TAS-102) plus bevacizumab', 'type': 'DRUG', 'description': 'Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sanming', 'status': 'RECRUITING', 'country': 'China', 'facility': 'SanMing First Hospital', 'geoPoint': {'lat': 26.24861, 'lon': 117.61861}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chen-Fei Zhou, MD, Ph.D', 'role': 'CONTACT', 'email': 'zcf12085@rjh.com.cn', 'phone': '+86-21-64370045'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jun Zhang', 'investigatorAffiliation': 'Ruijin Hospital'}}}}