Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
Study NCT ID:
NCT04460066
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2020-07-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-05', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major pathologic response rate', 'timeFrame': 'Two weeks after surgery.', 'description': 'The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': 'Two weeks after surgery.', 'description': 'The R0 resection rate of esophagectomy.'}, {'measure': 'pathological complete response rate', 'timeFrame': 'Two weeks after surgery.', 'description': 'The rate of pathologic 1a after neoadjuvant chemotherapy.'}, {'measure': 'disease free survival', 'timeFrame': 'From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.', 'description': 'The 2-year disease free survival of the whole group.'}, {'measure': 'disease free survival rate', 'timeFrame': 'From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.', 'description': 'The 2-year disease free survival rate of the whole group.'}, {'measure': 'event free survival', 'timeFrame': 'From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.', 'description': 'The 2-year event free survival of the whole group.'}, {'measure': 'event free survival rate', 'timeFrame': 'From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.', 'description': 'The 2-year event free survival rate of the whole group.'}, {'measure': 'overall survival rate', 'timeFrame': 'From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.', 'description': 'The 2-year overall survival rate of the whole group.'}, {'measure': 'overall survival', 'timeFrame': 'From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.', 'description': 'The 2-year overall survival of the whole group.'}, {'measure': 'adverse events rate', 'timeFrame': 'From the date of randomization to 90 days after the last chemotherapy.', 'description': 'The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal cancer', 'immunotherapy'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '9869669', 'type': 'BACKGROUND', 'citation': 'Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. doi: 10.1056/NEJM199812313392704.'}, {'pmid': '17028244', 'type': 'BACKGROUND', 'citation': 'Lin CC, Hsu CH, Cheng JC, Wang HP, Lee JM, Yeh KH, Yang CH, Lin JT, Cheng AL, Lee YC. Concurrent chemoradiotherapy with twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal cancer. Ann Oncol. 2007 Jan;18(1):93-98. doi: 10.1093/annonc/mdl339. Epub 2006 Oct 6.'}, {'pmid': '12881388', 'type': 'BACKGROUND', 'citation': 'Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7. doi: 10.1093/annonc/mdg328.'}, {'pmid': '25379852', 'type': 'BACKGROUND', 'citation': 'Shapiro J, van Hagen P, Lingsma HF, Wijnhoven BP, Biermann K, ten Kate FJ, Steyerberg EW, van der Gaast A, van Lanschot JJ; CROSS Study Group. Prolonged time to surgery after neoadjuvant chemoradiotherapy increases histopathological response without affecting survival in patients with esophageal or junctional cancer. Ann Surg. 2014 Nov;260(5):807-13; discussion 813-4. doi: 10.1097/SLA.0000000000000966.'}, {'pmid': '36882775', 'type': 'DERIVED', 'citation': 'Li Y, Zhou A, Liu S, He M, Chen K, Tian Z, Li Y, Qin J, Wang Z, Chen H, Tian H, Yu Y, Qu W, Xue L, He S, Wang S, Bie F, Bai G, Zhou B, Yang Z, Huang H, Fang Y, Li B, Dai X, Gao S, He J. Comparing a PD-L1 inhibitor plus chemotherapy to chemotherapy alone in neoadjuvant therapy for locally advanced ESCC: a randomized Phase II clinical trial : A randomized clinical trial of neoadjuvant therapy for ESCC. BMC Med. 2023 Mar 8;21(1):86. doi: 10.1186/s12916-023-02804-y.'}], 'seeAlsoLinks': [{'url': 'http://gco.iarc.fr/today/data/factsheets/cancers/6Oesophagus-fact-sheet.pdf.', 'label': 'GLOBOCAN 2018: oesophagus cancer fact sheet'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion Criteria:\n\n1. Aged 18 to 75 years old of either gender;\n2. A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;\n3. ECOG score 0-1;\n4. Estimated life expectancy \\>3 months;\n5. BMI ≥18.5kg/m2 or PG-SGA score A/B;\n6. The function of important organs meets the following requirements:\n\n 1. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;\n 2. ALT, AST and AKP ≤ 2.5×ULN;\n 3. serum albumin ≥ 30g/L;\n 4. total bilirubin ≤ 1.5×ULN;\n 5. serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥60 mL/min;\n 6. INR ≤ 1.5, PT≤ 1.5×ULN;\n7. Cardiac function: ≤I, pulmonary function: FEV1 \\>1.2L, FEV1% \\>40%, liver function: Child-Pugh 5-6;\n8. Serum HCG negative in premenopausal women ;\n9. Ability to understand the study and sign informed consent.\n\nKey exclusion Criteria:\n\n1. Cervical esophageal carcinoma;\n2. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);\n3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;\n4. Active autoimmune diseases;\n5. A history of allogeneic stem cell transplantation and organ transplantation;\n6. A history of interstitial lung disease or non-infectious pneumonia;\n7. Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;\n8. A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;\n9. Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);\n10. A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;\n11. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;\n12. Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).'}, 'identificationModule': {'nctId': 'NCT04460066', 'briefTitle': 'A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.', 'orgStudyIdInfo': {'id': 'ZKAB001-LEES-2020-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD-L1 group', 'description': 'All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).', 'interventionNames': ['Drug: anti-PD-L1 antibody', 'Drug: albumin bound paclitaxel', 'Drug: cisplatin', 'Procedure: radical resection of esophageal carcinoma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).', 'interventionNames': ['Drug: albumin bound paclitaxel', 'Drug: cisplatin', 'Drug: placebo', 'Procedure: radical resection of esophageal carcinoma']}], 'interventions': [{'name': 'anti-PD-L1 antibody', 'type': 'DRUG', 'otherNames': ['ZKAB001', 'Socazolimab Injection'], 'description': 'Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.', 'armGroupLabels': ['PD-L1 group']}, {'name': 'albumin bound paclitaxel', 'type': 'DRUG', 'otherNames': ['ABRAXANE'], 'description': 'Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .', 'armGroupLabels': ['PD-L1 group', 'placebo group']}, {'name': 'cisplatin', 'type': 'DRUG', 'description': 'Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.', 'armGroupLabels': ['PD-L1 group', 'placebo group']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.', 'armGroupLabels': ['placebo group']}, {'name': 'radical resection of esophageal carcinoma', 'type': 'PROCEDURE', 'description': 'Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.', 'armGroupLabels': ['PD-L1 group', 'placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'SHUGENG GAO, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences and Peking Union Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}