Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT05690035
Status:
WITHDRAWN
Last Update Posted:
2024-07-09
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With Fruquintinib for Metastatic pMMR/MSS 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': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C000591844', 'term': 'HMPL-013'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to slow patient recruiting. No patients were enrolled 12 months after study initiation.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 3 years', 'description': 'The proportion of patients with a confirmed complete response or partial response'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 3 years', 'description': 'PFS is defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 3 years', 'description': 'OS is defined as the time from enrollment to death due to any cause.'}, {'measure': 'Disease control rate', 'timeFrame': 'up to 3 years', 'description': 'The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD).'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'until 60 days after last patient last study drug treatment', 'description': 'Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer', 'mCRC']}, 'descriptionModule': {'briefSummary': 'This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.', 'detailedDescription': 'In this open-label phase II study, patients with ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan, will be scheduled for Tislelizumab (200mg ivdrip Q3W day1) + Fruquintinib (5mg/day Q3W day1-14) until intolerable toxicity, disease progression or death. Primary endpoint of this study is ORR and secondary endpoints are OS, PFS, DCR and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old (including 18 and 80);\n* Histologically confirmed colorectal adenocarcinoma and biopsy pathology confirmed MSS/pMMR;\n* Gene testing confirmed ARID1A gene mutation (nonsynonymous);\n* No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy;\n* Has received and failed ≥ 2 line of chemotherapy or progressed on or intolerable to oxaliplatin, irinotecan and fluorouracil chemotherapy after diagnosed with mCRC;\n* ECOG PS 0-2;\n* Able to swallow tablets;\n* Life expectancy of greater than 3 months;\n* Adequate bone marrow and organ function;\n* If female and of childbearing potential, must:\n* Have a negative pregnancy test ≤14 days prior to initiating study treatment\n* Agree to avoid pregnancy during and for 3 months after study treatment\n\nIf male with a partner of childbearing potential, must:\n\n* Agree to use adequate, medically approved, contraceptive precautions during and for 3 months after the last dose of study treatment.\n* Able and willing to provide written informed consent for the study.\n\nExclusion Criteria:\n\n* Any active autoimmune disease or history of autoimmune disease;\n* Those who are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purpose, and continue to use within 2 weeks before enrollment;\n* Severe allergic reaction to other monoclonal antibodies;\n* Subjects with clinical symptoms of untreated active brain metastasis or meningeal metastasis;\n* Have received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1 in the past;\n* Patients with high TMB (≥ 30Muts/Mb) and germline or somatic POLE/POLD1 gene mutations in the exonuclease domain;\n* There are clinical symptoms or diseases of heart that are not well controlled, such as: (a) heart failure of NYHA level 2 or above (b) unstable angina pectoris (c) myocardial infarction occurred within 1 year (d) clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention;\n* Known hereditary or acquired bleeding and thrombophilia or being treated with thrombolysis or anticoagulation;\n* Urinary protein ≥ ++, or the 24-hour urine protein quantification greater than 1.0g;\n* Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment;\n* Subjects with active infection;\n* Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 10\\^4 copies/ml; hepatitis C: HCV antibody positive);\n* Other advanced malignant tumors within 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ, ovarian cancer, thyroid cancer and breast cancer);\n* Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period;\n* Known or suspected to be allergic to the study drug or to any drug given in this trial;\n* Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not eligible according to the judgment of the investigator.'}, 'identificationModule': {'nctId': 'NCT05690035', 'briefTitle': 'Tislelizumab Combined With Fruquintinib for Metastatic pMMR/MSS Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'SL-B2022-653-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with mCRC', 'description': 'Tislelizumab 200mg ivdrip every 3 weeks; Fruquintinib 5mg qd day 1-14, every 3 weeks', 'interventionNames': ['Drug: Tislelizumab & Fruquintinib']}], 'interventions': [{'name': 'Tislelizumab & Fruquintinib', 'type': 'DRUG', 'description': 'combinational treatment of Tislelizumab and Fruquintinib until PD, intolerable toxicity, death or withdrawal of informed consent', 'armGroupLabels': ['patients with mCRC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University, Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Xiaoshi Zhang', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Peirong Ding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hutchmed', 'class': 'INDUSTRY'}, {'name': 'BeiGene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pei-Rong Ding', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}