Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-22 @ 12:47 AM
Study NCT ID:
NCT03748134
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2018-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-22', 'mcpReleaseN': 13, 'releaseDate': '2023-12-27'}], 'estimatedResultsFirstSubmitDate': '2023-12-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 746}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2018-11-18', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS in overall population', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 40 months.', 'description': 'To compare the overall survival of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC)'}, {'measure': 'OS in PD-L1 positive population', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 40 months.', 'description': 'To compare the OS of sintilimab vs. placebo, in combination with chemotherapy, for first-line treatment in subjects with PD-L1 positive, unresectable, locally advanced, recurrent or metastatic ESCC'}], 'secondaryOutcomes': [{'measure': 'ORR in overall population', 'timeFrame': 'From date of randomization up to 28 months.', 'description': 'To compare the objective response rate between the two treatment arms in ITT population'}, {'measure': 'PFS in overall populationsubjects in ITT population', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the progression-free survival between the two treatment arms in ITT population'}, {'measure': 'DCR in overall population', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the disease control rate between the two treatment arms in ITT population'}, {'measure': 'DoR in overall population', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the duration of response between the two treatment arms in ITT population'}, {'measure': 'ORR - PD-L1 positive', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the objective response rate between the two treatment arms in PD-L1 positive subjects in ITT population'}, {'measure': 'DCR - PD-L1 positive', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the disease control rate between the two treatment arms in PD-L1 positive subjects in ITT population'}, {'measure': 'DoR - PD-L1 positive', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the duration of response between the two treatment arms in PD-L1 positive subjects in ITT population'}, {'measure': 'PFS - PD-L1 positive', 'timeFrame': 'From date of randomization up to 28 months', 'description': 'To compare the progression-free survival between the two treatment arms in PD-L1 positive subjects in ITT population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESCC', 'Esophageal Cancer', 'Esophageal Neoplasms', 'Esophageal Neoplasms Malignant', 'Esophageal Squamous Cell Carcinoma', 'Neoplasms, Squamous Cell', 'Esophageal Diseases', 'Carcinoma, Squamous Cell', 'Gastrointestinal Diseases', 'Paclitaxel', 'Cisplatin', 'Fluorouracil', 'Antineoplastic Agents', 'Anti-PD-1', 'Sintilimab'], 'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38800802', 'type': 'DERIVED', 'citation': 'Lu Z, Kong L, Wang B, Wang J, Liu L, Shu Y, Yang L, Sun G, Cao G, Ji Y, Cui T, Liu H, Qiu W, Li N, Li G, Luo H, Hou X, Zhang Y, Yue W, Xue L, Liu Z, Pan Y, Gao S, Wang X, Pan Z, Zhang S, Lin G, Xie Y, Gu K, Ren T, Li W, Li T, Wang S, He W, Fan Y, Liang J, Xia B, Zhao L, Wang S, Shen L. Effects of sintilimab plus chemotherapy as first-line treatment on health-related quality of life in patients with advanced esophageal squamous cell carcinoma: results from the randomized phase 3 ORIENT-15 study. EClinicalMedicine. 2024 May 17;72:102623. doi: 10.1016/j.eclinm.2024.102623. eCollection 2024 Jun.'}, {'pmid': '37139963', 'type': 'DERIVED', 'citation': 'Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.'}, {'pmid': '35440464', 'type': 'DERIVED', 'citation': 'Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind multi-center, phase III study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.\n\nAfter the interim analysis conducted by the iDMC, an open-label assignment of experimental arm therapy will continue in regions outside of China, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histopathologically confirmed unresectable, locally advanced, recurrent or metastatic ESCC (excluding mixed adenosquamous carcinoma and other histological subtypes)\n* ECOG PS of 0 or 1\n* Subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/radiochemotherapy, time from the completion of last treatment to disease recurrence must be \\> 6 months Could provide archival or fresh tissues for PD-L1 expression analysis with obtainable results\n* Have at least one measurable lesion as per RECIST v1.1\n\nKey exclusion Criteria:\n\n* ESCC with endoscopy-confirmed near-complete obstruction requiring interventional therapy\n* Post stent implantation in the esophagus or trachea with risk of perforation\n* Received systemic treatment for advanced or metastatic ESCC.\n* Received a cumulative dose of cisplatin ≥ 300 mg/m2 and the last cisplatin dose was within 12 months of randomization or the first dose of study treatment in the open-label phase.\n* High risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation.\n* Hepatic metastasis \\> 50% of the total liver volume.\n* Received palliative therapy for a local lesion within 2 weeks prior to the first dose.\n* Received systemic treatment with Chinese traditional medicines with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment.\n* Received systemic immunosuppressants within 2 weeks prior to randomization, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media.'}, 'identificationModule': {'nctId': 'NCT03748134', 'briefTitle': 'Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)', 'orgStudyIdInfo': {'id': 'CIBI308A301'}, 'secondaryIdInfos': [{'id': '2020-000533-40', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomized Part: Experimental: Sintilimab + chemotherapy', 'description': "Sintilimab in combination with investigator's choice of chemotherapy\n\nTP regimen: Cisplatin + paclitaxel\n\nor\n\nCP regimen: Cisplatin + fluorourcil", 'interventionNames': ['Biological: Sintilimab', 'Drug: Cisplatin', 'Drug: Paclitaxel', 'Drug: Fluorouracil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomised Part: Active Comparator: Placebo + chemotherapy', 'description': "Placebo in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil", 'interventionNames': ['Drug: Cisplatin', 'Drug: Paclitaxel', 'Drug: Fluorouracil', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Open-label part: Sintilimab+ chemotherapy', 'description': "Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil", 'interventionNames': ['Biological: Sintilimab', 'Drug: Cisplatin', 'Drug: Paclitaxel', 'Drug: Fluorouracil']}], 'interventions': [{'name': 'Sintilimab', 'type': 'BIOLOGICAL', 'description': 'For weight \\<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1', 'armGroupLabels': ['Open-label part: Sintilimab+ chemotherapy', 'Randomized Part: Experimental: Sintilimab + chemotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75mg/m\\^2 IV Q3W day 1', 'armGroupLabels': ['Open-label part: Sintilimab+ chemotherapy', 'Randomised Part: Active Comparator: Placebo + chemotherapy', 'Randomized Part: Experimental: Sintilimab + chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': '87.5 mg/m\\^2 IV Q3W day 1, day 8 for first cycle and 175mg/m\\^2 IV Q3W day 1 after first cycle', 'armGroupLabels': ['Open-label part: Sintilimab+ chemotherapy', 'Randomised Part: Active Comparator: Placebo + chemotherapy', 'Randomized Part: Experimental: Sintilimab + chemotherapy']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': '800 mg/m\\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W', 'armGroupLabels': ['Open-label part: Sintilimab+ chemotherapy', 'Randomised Part: Active Comparator: Placebo + chemotherapy', 'Randomized Part: Experimental: Sintilimab + chemotherapy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'For weight \\<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1', 'armGroupLabels': ['Randomised Part: Active Comparator: Placebo + chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Heritage Healthcare - Virginia K. 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Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fortrea', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}