Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
Study NCT ID:
NCT06858969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': '24 months', 'description': 'Evaluated using RECIST 1.1 criteria'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '24 months', 'description': 'Evaluated using RECIST 1.1 criteria'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '24 months', 'description': 'Evaluated using RECIST 1.1 criteria'}, {'measure': 'safety', 'timeFrame': '24 months', 'description': 'Based on NCI-CTCAE 5.0 criteria.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years, regardless of gender; Histologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma; No prior systemic antitumor therapy received for metastatic/recurrent colorectal adenocarcinoma; For subjects who have received prior neoadjuvant/adjuvant therapy, the interval between the last treatment and recurrence/progression must exceed 12 months; ECOG performance status 0-1; At least one measurable lesion (per RECIST v1.1 criteria); Expected survival ≥3 months;\n\nOrgan function must meet the following requirements prior to the first dose of the investigational drug:\n\n1. Hematological function (no blood transfusion or growth factor administration within 14 days before screening):\n\n Absolute neutrophil count ≥1.5×10\\^9/L, Platelet count ≥100×10\\^9/L, Hemoglobin ≥90 g/L;\n2. Hepatic and renal function (no albumin infusion within 14 days before screening):\n\n Total bilirubin ≤1.5×ULN, Serum albumin ≥25 g/L, ALT and AST ≤2.5×ULN (≤5.0×ULN for patients with liver metastases), Serum creatinine ≤1.5×ULN;\n3. Coagulation function:\n\n INR ≤1.5×ULN, PT and APTT ≤1.5×ULN;\n4. Urinalysis:\n\nUrine protein \\<2+; for subjects with baseline urine protein ≥2+, 24-hour urine protein quantification must be \\<1 g; Subjects (including females and males) must agree to use effective contraception from signing the informed consent form until 180 days after the last dose of the investigational drug. Females of childbearing potential must not be pregnant or breastfeeding; Prior treatment-related adverse events (AEs) must have resolved to ≤Grade 1 (per NCI CTCAE v5.0, except alopecia); Voluntary participation in this clinical trial with written informed consent.\n\nExclusion Criteria:\n\n* Subjects with known tumor microsatellite instability-high (MSI-H) status.\n\nPrior treatment with histone deacetylase (HDAC) inhibitors, including but not limited to chidamide or entinostat.\n\nPrior postoperative adjuvant therapy targeting EGFR or VEGF/VEGFR, including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of these agents.\n\nPrior treatment with T-cell co-stimulation or immune checkpoint therapies, including CTLA-4 inhibitors, PD-1/PD-L1/PD-L2 inhibitors, or other T-cell-targeted drugs.\n\nActive hepatitis B (HBV DNA ≥ 500 IU/mL) or hepatitis C (HCV antibody-positive with HCV-RNA above the lower limit of detection).\n\nCentral nervous system (CNS) metastases or leptomeningeal metastases.\n\nHistory of cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia within the past 6 months (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females, calculated via Fridericia's formula).\n\nClinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring intervention and deemed ineligible by the investigator.\n\nCardiac dysfunction (NYHA class III/IV) or left ventricular ejection fraction (LVEF) \\< 50% on echocardiography.\n\nHistory of other malignancies within 5 years prior to signing informed consent, except cured basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ.\n\nImmunodeficiency, including HIV positivity, congenital/acquired immune deficiency, or history of organ/allogeneic bone marrow transplantation.\n\nActive autoimmune disease or autoimmune disease history (e.g., interstitial pneumonia, colitis, hepatitis, thyroid dysfunction). Exceptions: vitiligo, childhood asthma/allergies in remission without adult intervention, stable hypothyroidism on hormone replacement, or type I diabetes on stable insulin.\n\nUncontrolled hypertension (systolic ≥ 150 mmHg and/or diastolic ≥ 100 mmHg).\n\nHistory of hypertensive crisis or hypertensive encephalopathy.\n\nSystemic corticosteroid use (\\>10 mg prednisone daily or equivalent) or immunosuppressants within 2 weeks prior to treatment.\n\nActive systemic infection requiring IV antibiotics \\>7 days within 2 weeks prior to treatment.\n\nAnti-tuberculosis therapy within 1 year prior to treatment.\n\nHistory of substance abuse, alcoholism, or psychiatric/neurological disorders (e.g., epilepsy, dementia, hepatic encephalopathy).\n\nParticipation in other clinical trials with investigational drugs within 4 weeks prior to treatment.\n\nHypersensitivity to macromolecular protein preparations or any component of the study drugs.\n\nLive vaccination within 4 weeks prior to treatment.\n\nMajor surgery within 4 weeks prior to treatment or planned during the study.\n\nHemoptysis (≥2.5 mL of bright red blood) or clinically significant gastrointestinal bleeding within 2 months prior to treatment.\n\nCurrent or history of gastrointestinal obstruction, unless resolved with treatment and deemed eligible by the investigator.\n\nHemorrhagic tendency or clinically significant coagulopathy.\n\nUnhealed wounds, active ulcers, or untreated fractures.\n\nRecent use of antiplatelet/anticoagulant agents:\n\nAspirin (\\>325 mg/day) or clopidogrel (\\>75 mg/day) within 10 days prior to treatment;\n\nTherapeutic anticoagulation (except low-molecular-weight heparin) within 2 weeks prior to treatment.\n\nGastrointestinal abnormalities affecting drug absorption (e.g., dysphagia, chronic diarrhea, gastrectomy).\n\nAny condition that, in the investigator's judgment, increases study risk, confounds results, or renders the patient unsuitable for enrollment."}, 'identificationModule': {'nctId': 'NCT06858969', 'briefTitle': 'Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Phase II Clinical Study of Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX as First-Line Treatment for Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CSIIT-Q100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': "PD-1 inhibitor: Dose determined per the manufacturer's instructions or investigator's discretion based on patient status.\n\nBevacizumab: 7.5 mg/kg via intravenous infusion every 3 weeks (Q3W).\n\nXELOX regimen:\n\nOxaliplatin: 130 mg/m² via intravenous infusion on Day 1;\n\nCapecitabine: 1000 mg/m² orally twice daily on Days 1-14;\n\nRepeated every 3 weeks for 6 cycles.\n\nMaintenance therapy after 6 cycles (experimental group):\n\nChidamide: Administered at the maximum tolerated dose/recommended phase II dose (MTD/RP2D), orally twice weekly (on Days 1, 4, 8, 11, 15, and 18 of each cycle), 30 minutes after meals.\n\nPD-1 inhibitor, Bevacizumab, and Capecitabine: Continued at the same doses and schedules as during the initial treatment phase.", 'interventionNames': ['Drug: Treatment group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-care control group', 'description': 'XELOX + Bevacizumab: Doses identical to the experimental group (Oxaliplatin 130 mg/m², Capecitabine 1000 mg/m², Bevacizumab 7.5 mg/kg Q3W) for 6 cycles.\n\nMaintenance therapy after 6 cycles: Bevacizumab (7.5 mg/kg Q3W) and Capecitabine (1000 mg/m² orally twice daily on Days 1-14 of each cycle).', 'interventionNames': ['Drug: Standard-of-care control group']}], 'interventions': [{'name': 'Treatment group', 'type': 'DRUG', 'description': 'Chidamide+XELOX + Bevacizumab+PD-1', 'armGroupLabels': ['Treatment group']}, {'name': 'Standard-of-care control group', 'type': 'DRUG', 'description': 'XELOX + Bevacizumab+PD-1', 'armGroupLabels': ['Standard-of-care control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'AIPING ZHOU', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}