Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-08 @ 5:31 AM
Study NCT ID:
NCT06547203
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
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': 'D000068818', 'term': 'Cetuximab'}, {'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D000077146', 'term': 'Irinotecan'}], '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To investigate the objective response rate (ORR) of cetuximab combined with toripalimab and irinotecan in right-sided mCRC patients with negative ultraselected RAS/BRAF wild-type who have progressed after previous treatments with bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2029-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months', 'description': 'The proportion of patients who have achieved partial response (PR) plus complete response (CR), as assessed by the investigator using RECIST v1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate', 'timeFrame': 'Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months', 'description': 'The proportion of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD) following treatment initiation.'}, {'measure': 'Duration of Response', 'timeFrame': 'Assessed after every 4 cycles (each cycle is 14 days) for up to 24 months', 'description': 'Length of time from the initial detection of a measurable response (complete response or partial response) to the treatment until the first documentation of disease progression or recurrence'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'Assessed up to 24 months', 'description': 'The length of time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.'}, {'measure': 'Overall Survival', 'timeFrame': 'Assessed throughout the study duration (5 years)', 'description': 'Defined as the time from the start of study treatment to death due to any cause'}, {'measure': 'Adverse events (Treatment-related)', 'timeFrame': 'Assessed throughout the study duration (5 years)', 'description': 'Assessment of adverse events and their severity according to NCI CTCAE version 5.0 criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic colorectal cancer', 'RAS/BRAF wild type', 'Right-sided', 'Cetuximab', 'PD-1 inhibitor'], 'conditions': ['Colorectal Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.', 'detailedDescription': 'The present study focuses on exploring the effectiveness and safety of cetuximab combined with a PD-1 inhibitor and irinotecan in treating refractory, right-sided metastatic colorectal cancer (mCRC) patients who are negative ultraselected for RAS/BRAF mutations. Colorectal cancer ranks among the most prevalent digestive malignancies globally, with right-sided mCRC generally exhibiting poorer outcomes than left-sided cases. Current treatment guidelines vary based on genetic mutations and tumor location, recommending cetuximab for left-sided RAS/BRAF wild-type mCRC and alternative therapies for right-sided or mutated cases. Despite limited clinical data on EGFR inhibitors for right-sided mCRC, retrospective analyses suggest varying efficacy outcomes. The study aims to address these gaps by investigating cetuximab and PD-1 inhibitor combination therapy in this specific patient population, potentially enhancing treatment options for refractory mCRC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma.\n* Primary tumor located in the right colon.\n* Metastatic disease with at least one measurable lesion according to RECIST v1.1 criteria.\n* Histologically tested as RAS/BRAF V600E wild-type and negative ultraselected for mutations including: RAS/BRAF V600E/PIK3CA/PTEN/EGFR (ECD), HER2 and MET amplification, and ALK/RET/NTRK1 gene fusions.\n* Patients who have progressed after previous treatments including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil, with tumor progression occurring during or within 3 months after irinotecan treatment.\n* No prior treatment with anti-EGFR or PD-1 antibodies.\n* Normal hematological function (platelets \\>90×10\\^9/L; white blood cells \\>3×10\\^9/L; neutrophils \\>1.5×10\\^9/L).\n* Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN.\n* No ascites, normal coagulation function, albumin ≥35 g/L.\n* Liver function classified as Child-Pugh grade A.\n* Serum creatinine less than ULN, or calculated creatinine clearance \\>50 ml/min (using the Cockcroft-Gault formula).\n* At least one measurable lesion according to RECIST v1.1 criteria.\n* ECOG performance status of 0-2.\n* Expected survival \\>3 months.\n* Signed written informed consent.\n* Willing and able to undergo follow-up until death or study completion or termination.\n\nExclusion Criteria:\n\n* Severe arterial thrombosis or ascites.\n* Bleeding tendencies or coagulation disorders.\n* Hypertensive crisis or hypertensive encephalopathy.\n* Severe uncontrolled systemic complications such as infections or diabetes.\n* Clinically significant cardiovascular diseases such as cerebrovascular accident (within 6 months prior to enrollment), myocardial infarction (within 6 months prior to enrollment), uncontrolled hypertension despite appropriate medication, unstable angina, congestive heart failure (NYHA grade 2-4), or arrhythmias requiring medication.\n* History of or physical examination showing central nervous system diseases (e.g., primary brain tumor, uncontrolled epilepsy, any history of brain metastasis or stroke).\n* Other malignancies within the past 5 years (except for basal cell carcinoma of the skin after curative surgery and/or carcinoma in situ of the cervix).\n* Use of immunosuppressive drugs within 1 week before treatment, excluding nasal, inhaled, or other topical steroids or physiological doses of systemic steroids (i.e., not exceeding 10 mg/day of prednisone or an equivalent dose of other steroids) or steroids used to prevent contrast agent allergies.\n* Steroid-dependent interstitial lung disease.\n* Known active autoimmune disease requiring symptomatic treatment or history of such disease within the past 2 years. Patients with vitiligo, psoriasis, alopecia, or -Graves' disease not requiring systemic treatment within the past 2 years, hypothyroidism requiring only thyroid hormone replacement, and type I diabetes requiring only insulin replacement can be enrolled.\n* Known history of primary immunodeficiency.\n* Known active tuberculosis.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Receipt of any investigational drug treatment within the last 28 days before the study.\n* Allergy to any drugs in the study.\n* Pregnant or breastfeeding women.\n* Women of childbearing potential (within 2 years of last menstruation) or men capable of fathering a child who are not using or refuse to use effective non-hormonal contraceptive methods (e.g., intrauterine device, barrier method combined with spermicide, or sterilization).\n* Inability or unwillingness to comply with the study protocol.\n* Presence of any other disease, functional impairment caused by metastatic lesions, or suspicious conditions found during a physical examination indicating a contraindication to the study drugs or high risk for treatment-related complications."}, 'identificationModule': {'nctId': 'NCT06547203', 'briefTitle': 'Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study', 'orgStudyIdInfo': {'id': 'CITRUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cetuimab plus toripalimab and irinotecan', 'description': 'Single Arm study, with patients receiving:\n\nCetuximab: 500 mg/m², intravenous infusion, once every 2 weeks. Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks. Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks.\n\nPatients will continue treatment until any of the following conditions occur: the researcher determines there is no longer a clinical benefit, intolerable toxicity occurs, a new anti-tumor treatment is initiated, withdrawal of informed consent, loss to follow-up, death, or other conditions specified in the protocol requiring termination of treatment.', 'interventionNames': ['Drug: Cetuximab', 'Drug: Toripalimab', 'Drug: Irinotecan']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': 'Cetuximab: 500 mg/m², intravenous infusion, once every 2 weeks', 'armGroupLabels': ['Cetuimab plus toripalimab and irinotecan']}, {'name': 'Toripalimab', 'type': 'DRUG', 'otherNames': ['Loqtorzi'], 'description': 'Toripalimab: 3 mg/kg, intravenous infusion, once every 2 weeks.', 'armGroupLabels': ['Cetuimab plus toripalimab and irinotecan']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['CPT-11'], 'description': 'Irinotecan: 150 mg/m², intravenous infusion, once every 2 weeks.', 'armGroupLabels': ['Cetuimab plus toripalimab and irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yuhong, MD', 'role': 'CONTACT', 'email': 'liyh@sysucc.org.cn', 'phone': '020-87342487'}, {'name': 'Li Yuhong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yuhong Li, PhD', 'role': 'CONTACT', 'email': 'liyh@sysucc.org.cn', 'phone': '87342487', 'phoneExt': '020'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data and materials used in this study can be made available following study completion upon reasonable request to the corresponding author, subject to ethical and legal considerations and applicable data-sharing agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yuhong Li', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}