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
- Diseases
- Gastric and esophageal cancer
- 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
Sites (86)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Heping Hospital Affiliated to Changzhi Medical College Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| People's hospital of Deyang city Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Fujian | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fujian | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fujian | China | Unknown status |
| Lanzhou University Second Hospital Coordinator of this site? Confirm its status | Gansu | China | Unknown status |
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Sun Yat-Sen University Cancer Center Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Guangdong | China | Unknown status |
| Guangxi Medical University Affiliated Tumor Hospital Coordinator of this site? Confirm its status | Guangxi | China | Unknown status |
| Meizhou Hospital Affiliated to Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Hainan | China | Unknown status |
| Affiliated Hospital of Hebei University Coordinator of this site? Confirm its status | Hebei | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Anhui Provincial Cancer Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Harbin medical university cancer hospital Coordinator of this site? Confirm its status | Heilongjiang | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Henan | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Henan | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Henan | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Hubei | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Hubei | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Hunan | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Jiangxi | China | Unknown status |
| The First Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Jiangxi | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Nantong Tumor Hospital Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Qinghai Provincial People's Hospital Coordinator of this site? Confirm its status | Qinghai | China | Unknown status |
| Quanzhou First Hospital of Fujian Province Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| Hainan Third People's Hospital Coordinator of this site? Confirm its status | Sanya | China | Unknown status |
| Linyi Cancer Hospital Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Sichuan | China | Unknown status |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| First Affiliated Hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Yunnan | China | Unknown status |
| Hangzhou Cancer Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Unknown status |
| Hwa Mei Hospital, University of Chinese Academy of Sciences Coordinator of this site? Confirm its status | Zhejiang | China | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Madrid Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia (INCLIVA) Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Centre Hospitalier Universitaire d'Amiens - Hopital Sud Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hopital Europeen Georges Pompidou - Digestive Oncology Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeongnam | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Chulabhorn Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Rajavithi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Songklanagarind Hospital Prince of Songkla University Coordinator of this site? Confirm its status | Hat Yai | Thailand | Unknown status |
| Chiayi Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
Related publications
- Ociperlimab and tislelizumab in advanced esophageal squamous cell carcinoma (AdvanTIG-203): a phase II study.Nat Commun · 2026 · PMID 42901884
This page is information, not medical advice. Discuss any trial with your doctor.