Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04984018
Status:
UNKNOWN
Last Update Posted:
2021-07-30
First Post:
2021-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chidamide Plus Camrelizumab as Second-line Therapy for Advanced ESCC Treated With PD-1 Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'C000631724', 'term': 'camrelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tumor mutation burden (TMB)', 'timeFrame': 'up to 1 year', 'description': 'Total number of non-synonymous mutations in each coding region of the tumor genome'}, {'measure': 'PD-L1 CPS', 'timeFrame': 'up to 1 year', 'description': 'Number of PD-L1 staining cells (tumor cells)/Total tumor cellsk\\*100%'}], 'primaryOutcomes': [{'measure': 'OS', 'timeFrame': 'up to 2 years', 'description': 'From date of treatment until the date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 1 year', 'description': 'Defined as the proportion of patients with a documented complete response, partial response(CR+PR)'}, {'measure': 'PFS', 'timeFrame': 'up to 1 year', 'description': 'From date of treatment until the date of first documented progression or date of death from any cause'}, {'measure': 'DOR', 'timeFrame': 'up to 1 year', 'description': 'Refers to the time when the tumor is first evaluated as CR or PR until the first assessment is PD (Progressive Disease) or any cause of death.'}, {'measure': 'DCR', 'timeFrame': 'up to 1 year', 'description': 'Defined as the proportion of patients with a documented complete response, partial response and stable response(CR+PR+SD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe and evaluate the efficacy and safety of chidamide plus camrelizumab as second-line therapy for advanced esophageal squamous cell carcinoma treated with PD-1 blockade', 'detailedDescription': 'Although immune checkpoint inhibitors (ICIs) have been tested in esophageal squamous cell carcinoma(ESCC) with demonstrated clinical efficacy，a significant number of patients who have an initial response will develop a secondary resistance and relapse. recent studies on the role of epigenetics in immune evasion have exposed a key role for epigenetic modulators in augmenting the tumour microenvironment and restoring immune recognition and immunogenicity. These discoveries have established a highly promising basis for studies using combined epigenetic and immunotherapeutic agents as anti-cancer therapies. Chidamide is a novel orally active benzamide-type histone deacetylase inhibitor that has shown in vitro activities against a wide array of neoplasms. Hence, the study of chidamide plus camrelizumab as second-line therapy for advanced ESCC treated with PD-1 blockade was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.\n2. Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).\n3. Histologically confirmed diagnosis of ESCC.\n4. Have PD after first-line of PD-1 blockade treatment for unresectable, locally advanced, recurrent or metastatic ESCC.\n5. Measurable disease per RECIST v1.1 assessed by the local investigator\n6. ECOG PS 0 or 1\n7. Newly obtained (preferred) or archival tissue sample available\n8. Negative urine or serum pregnancy test within 72 h before treatment(females)\n9. Willing to use an adequate method of contraception throughout the study and for 120 days after the last dose of study medication and up to 180 days after the last dose of cisplatin\n10. Adequate haematologic function, defined as ANC ≥ 1500/μl, platelet count ≥ 100,000/μl and haemoglobin ≥ 9.0 g/dl or ≥5.6 mmol/l\n11. Adequate renal function, defined as creatinine ≤ 1.5 × ULN or measured or calculated creatinine clearance ≥ 60 mL/min for those with creatinine levels 1.5 × ULN\n12. Adequate hepatic function, defined as total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN, and ALT/AST levels ≤ 2.5 × ULN\n13. Adequate coagulation function, defined as INR ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case PT or aPTT should be within the therapeutic range\n14. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with evidence of fistula (either esophageal/bronchial or esophageal/aorta).\n2. Evidence of complete esophageal obstruction not amenable to treatment.\n3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n4. Active autoimmune diseases or history of autoimmune diseases that may relapse\n5. Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).\n6. Uncontrolled diabetes or \\> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before treatment.\n7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).\n8. History of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, etc.\n9. Infection (including tuberculosis infection, etc) that requires systemic antibacterial, antifungal or antiviral therapy within 14 days before treatment.\n10. A history of severe hypersensitivity reactions to chidamide and monoclonal antibodies.\n11. Patients with toxicities (as a result of prior anticancer therapy) that have not recovered to ≤Grade 2 or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).'}, 'identificationModule': {'nctId': 'NCT04984018', 'briefTitle': 'Chidamide Plus Camrelizumab as Second-line Therapy for Advanced ESCC Treated With PD-1 Blockade', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'An Single-arm Open-label Phase II Study of Chidamide Plus Camrelizumab as Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma Treated With PD-1 Blockade.', 'orgStudyIdInfo': {'id': 'WF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chidamide plus Camrelizumab', 'description': 'Pts received 200 mg camrelizumab intravenously every 2 weeks and Chidamide 30mg orally twice (biw) per week for 4 consecutive weeks every 6 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.', 'interventionNames': ['Drug: chidamide + camrelizumab']}], 'interventions': [{'name': 'chidamide + camrelizumab', 'type': 'DRUG', 'description': 'Pts received 200 mg camrelizumab intravenously every 2 weeks and Chidamide 30mg orally twice (biw) per week for 4 consecutive weeks every 6 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.', 'armGroupLabels': ['Chidamide plus Camrelizumab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Feng Wang, Doctor', 'role': 'CONTACT', 'email': 'fengw010@163.com', 'phone': '13938244776'}], 'overallOfficials': [{'name': 'Feng Wang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Feng Wang', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}