Sintilimab or Placebo With Chemotherapy in Esophageal Squamous Cell Carcinoma ( ORIENT-15 )
NCT ID: NCT03748134
Last Updated: 2023-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
746 participants
INTERVENTIONAL
2018-12-24
2023-07-29
Brief Summary
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After 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Randomized Part: Experimental: Sintilimab + chemotherapy
Sintilimab in combination with investigator's choice of chemotherapy
TP regimen: Cisplatin + paclitaxel
or
CP regimen: Cisplatin + fluorourcil
Sintilimab
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Cisplatin
75mg/m\^2 IV Q3W day 1
Paclitaxel
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
Fluorouracil
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Randomised Part: Active Comparator: Placebo + chemotherapy
Placebo in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil
Cisplatin
75mg/m\^2 IV Q3W day 1
Paclitaxel
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
Fluorouracil
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Placebo
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Open-label part: Sintilimab+ chemotherapy
Sintilimab in combination with investigator's choice of chemotherapy TP regimen: Cisplatin + paclitaxel or CP regimen: Cisplatin + fluorourcil
Sintilimab
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Cisplatin
75mg/m\^2 IV Q3W day 1
Paclitaxel
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
Fluorouracil
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Interventions
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Sintilimab
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Cisplatin
75mg/m\^2 IV Q3W day 1
Paclitaxel
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
Fluorouracil
800 mg/m\^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
Placebo
For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
Eligibility Criteria
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Inclusion Criteria
* ECOG PS of 0 or 1
* 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
* Have at least one measurable lesion as per RECIST v1.1
Exclusion Criteria
* Post stent implantation in the esophagus or trachea with risk of perforation
* Received systemic treatment for advanced or metastatic ESCC.
* 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.
* High risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation.
* Hepatic metastasis \> 50% of the total liver volume.
* Received palliative therapy for a local lesion within 2 weeks prior to the first dose.
* 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.
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fortrea
INDUSTRY
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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St. Joseph Heritage Healthcare - Virginia K. Crosson Cancer Center
Anaheim, California, United States
UC Irvine
Orange, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
IACT Health - John B. Amos Cancer center
Columbus, Georgia, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Texas Oncology, P.A.
Austin, Texas, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Border Medical Oncology
East Albury, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
University Hospital Gent
Ghent, Corneel Heymanslaan 10, Belgium
Universitair Ziekenhuis Leuven
Leuven, Herestraat 49, Belgium
Cliniques Universitaires Saint-Luc Av.
Brussels, Hippocrate 10, Belgium
Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Regional de Verviers
Verviers, , Belgium
Beijing Cancer Hospital
Beijing, , China
Hôpital Jean Minjoz
Bettancourt-la-Ferrée, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Estaing
Clermont-Ferrand, , France
Faculte de Medecine
Dijon, , France
Universite de Bourgogne - Faculte de Medecine - INSERM U866
Dijon, , France
Oscar Lambret Centre
Lille, , France
CHU Hôpital de la Timone
Marseille, , France
Hôpital Européen Georges Pompidou
Paris, , France
CHU de Poitiers
Poitiers, , France
Hôpital Charles-Nicolle de Rouen
Rouen, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Országos Onkológiai Intézet
Budapest, Ráth György U. 7-9, Hungary
Jósa András Oktatókórház
Nyíregyháza, Szent István U. 68, Hungary
University Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, , Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Parc Taulí Sabadell Hospital Universitari
Sabadell, , Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Consorci Hospital General Universitari de València
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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2020-000533-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
CIBI308A301
Identifier Type: -
Identifier Source: org_study_id
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