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NCT04732494CompletedPhase 2

Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 31 Jan 2025

Brief summary (registry, in English)

A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
125 (actual)
First submitted
25 Jan 2021
Start date
31 Mar 2021
Primary completion date
1 Feb 2023
Lead sponsor
BeiGene
NCT number
NCT04732494
EudraCT number
2020-004658-32

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 125
  • From 31 Mar 2021 to the primary completion date, 1 Feb 2023
  • 86 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  • Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other illness

  • Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).

Other

  • Evidence of complete esophageal obstruction not amenable to treatment.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).

Who the study is looking for

  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
  • Have progressive disease during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
  • Have measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Have confirmed programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% in tumor tissues tested by the central lab.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (86)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Heping Hospital Affiliated to Changzhi Medical College
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ChangzhiChinaUnknown status
The First People's Hospital Of Changzhou
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ChangzhouChinaUnknown status
People's hospital of Deyang city
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DeyangChinaUnknown status
Zhongshan Hospital Xiamen University
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FujianChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FujianChinaUnknown status
Fujian Cancer Hospital
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FujianChinaUnknown status
Lanzhou University Second Hospital
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GansuChinaUnknown status
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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GuangdongChinaUnknown status
Nanfang Hospital of Southern Medical University
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GuangdongChinaUnknown status
Sun Yat-Sen University Cancer Center
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GuangdongChinaUnknown status
The Sixth Affiliated Hospital, Sun Yat-sen University
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GuangdongChinaUnknown status
Cancer Hospital of Shantou University Medical College
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GuangdongChinaUnknown status
Guangxi Medical University Affiliated Tumor Hospital
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GuangxiChinaUnknown status
Meizhou Hospital Affiliated to Sun Yat-sen University
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GuangzhouChinaUnknown status
Guangdong Provincial Hospital of Chinese Medicine
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GuangzhouChinaUnknown status
Hainan General Hospital
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HainanChinaUnknown status
Affiliated Hospital of Hebei University
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HebeiChinaUnknown status
The Second Hospital of Anhui Medical University
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HefeiChinaUnknown status
Anhui Provincial Cancer Hospital
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HefeiChinaUnknown status
Harbin medical university cancer hospital
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HeilongjiangChinaUnknown status
Henan Cancer Hospital
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HenanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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HenanChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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HenanChinaUnknown status
Hubei Cancer Hospital
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HubeiChinaUnknown status
Xiangyang Central Hospital
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HubeiChinaUnknown status
Hunan Cancer Hospital
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HunanChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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JiangxiChinaUnknown status
The First Affiliated Hospital of Nanchang University
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JiangxiChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Yunnan Cancer Hospital
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KunmingChinaUnknown status
Nantong Tumor Hospital
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NantongChinaUnknown status
Qinghai Provincial People's Hospital
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QinghaiChinaUnknown status
Quanzhou First Hospital of Fujian Province
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QuanzhouChinaUnknown status
Hainan Third People's Hospital
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SanyaChinaUnknown status
Linyi Cancer Hospital
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ShandongChinaUnknown status
Weifang People's Hospital
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ShandongChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital & Institute
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ShenyangChinaUnknown status
Sichuan Provincial People's Hospital
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SichuanChinaUnknown status
Shanxi Provincial People's Hospital
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TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute & Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Affiliated Hospital of Jiangnan University
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WuxiChinaUnknown status
First Affiliated Hospital of Xiamen University
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XiamenChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Northern Jiangsu People's Hospital
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YangzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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YunnanChinaUnknown status
Hangzhou Cancer Hospital
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ZhejiangChinaUnknown status
Hwa Mei Hospital, University of Chinese Academy of Sciences
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ZhejiangChinaUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitario Vall d'Hebron
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BarcelonaSpainUnknown status
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario Madrid Sanchinarro
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MadridSpainUnknown status
Hospital Regional Universitario de Malaga
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MálagaSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Hospital Clinico Universitario de Valencia (INCLIVA)
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ValenciaSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status
Centre Hospitalier Universitaire d'Amiens - Hopital Sud
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AmiensFranceUnknown status
Hopital de la Timone
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MarseilleFranceUnknown status
Hopital Europeen Georges Pompidou - Digestive Oncology
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ParisFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
Ajou University Hospital
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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JeongnamSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Chulabhorn Hospital
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BangkokThailandUnknown status
Phramongkutklao Hospital
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Rajavithi Hospital
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Chiang MaiThailandUnknown status
Songklanagarind Hospital Prince of Songkla University
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Hat YaiThailandUnknown status
Chiayi Chang Gung Memorial Hospital
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Chiayi CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.