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Immunotherapy shows promise against advanced liver cancer

NCT ID NCT03412773

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested a new immunotherapy drug, tislelizumab, against the standard targeted therapy sorafenib in 684 adults with advanced liver cancer that could not be removed by surgery. Participants received either tislelizumab intravenously every three weeks or sorafenib pills twice daily. The main goal was to see if tislelizumab improved overall survival. A smaller safety run-in was done in Japan to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tislelizumab (a type of immunotherapy) and sorafenib (a targeted therapy)
What this could lead to
If successful, tislelizumab could become a new first-line treatment option for advanced liver cancer, potentially improving survival and quality of life.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Immunotherapy can cause immune-related side effects, and not all patients respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

684 people

The number who actually took part.

Started

Dec 2017

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Safety Run-In Sub-study Eligibility Criteria: The study included adult Japanese participants (≥ 20 years) with histologically confirmed hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C or B. Eligible participants had either received, were ineligible for, or declined standard treatment. Additional requirements were a Child-Pugh A classification within 7 days before enrollment, at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1. Main Study Key Inclusion Criteria: 1. Histologically confirmed diagnosis of HCC 2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach 3. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy \[Japan only\]) 4. Measurable disease 5. Child-Pugh score A 6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1 7. Adequate organ function Main Study Key Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology 2. Tumor thrombus involving main trunk of portal vein or inferior vena cava 3. Loco-regional therapy to the liver within 28 days before randomization 4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization 5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment 6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse 7. Participant with any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization 8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy 9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) \> 450 msec at Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC)

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Center Hospital of the National Center For Global Health and Medicine

    Shinjukuku, Tokyo, 162-8655, Japan

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44093, France

  • Centrum Badan Klinicznych

    Wroclaw, 51-149, Poland

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • Charite Universitatsmedizin Berlin

    Berlin, 13353, Germany

  • Chi Mei Medical Center

    Tainan, 710, Taiwan

  • Chiba University Hospital Gastroenterological Medicine

    Chiba, 260-8677, Japan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Chru de Lille Hopital Claude Huriez Hepato Gastro Enterologie

    Lille, 59037, France

  • Chu Besancon Hopital Jean Minjoz

    Doubs, 25030, France

  • Chu Caen Normandie

    Caen, 14033, France

  • Chu Montpellier Hopital Saint Eloi

    Montpellier, 34295, France

  • Chu Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270, France

  • Chu de Grenoble Oncology

    Grenoble, 38043, France

  • Chu de Poitiers Site de La Mileterie

    Poitiers, 86000, France

  • Clinical Research Center Sp Z Oo, Medic R Sp K

    Poznan, 60-569, Poland

  • Ehime Prefectural Central Hospital Gastroenterologic Medicine

    Matsuyama, Ehime, 790-0024, Japan

  • Fakultni Nemocnice Brno

    Brno, 62500, Czechia

  • Fakultni Nemocnice V Motole

    Prague, 150 06, Czechia

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002, China

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Beaujon

    Clichy, 92210, France

  • Hopital Larchet Chu Nice

    Nice, 6200, France

  • Hopital Paul Brousse Aphp

    Villejuif, 94800, France

  • Hopital Robert Debre

    Reims, 51056, France

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Hm Madrid Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hyogo Medical University Hospital

    Nishinomiyashi, Hyōgo, 663-8501, Japan

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100, Italy

  • Iwate Medical University Hospital

    Yahabacho Shiwagun, Iwate, 028-3695, Japan

  • Japanese Red Cross Medical Center Gastroenterology

    Shibuyaku, Tokyo, 150-8935, Japan

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008, China

  • Jilin Province Peoples Hospital

    Changchun, Jilin, 130021, China

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kindai University Hospital

    Sayama, Osaka, 589-8511, Japan

  • Kings College

    London, SE5 9RS, United Kingdom

  • Kliniken Essen Mitte Evang Huyssens Stiftung

    Essen, 45136, Germany

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305, Taiwan

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Military Hospital of China

    Beijing, Beijing Municipality, 100039, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy

    Warsaw, 02-034, Poland

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Kyushu Medical Center

    Fukuokacity, Fukuoka, 810-8563, Japan

  • National Hospital Organization Nagasaki Medical Center Gastroenterology

    Ōmura, Nagasaki, 856-8562, Japan

  • Nho Osaka National Hospital

    Osakashi, Osaka, 540-0006, Japan

  • Nihon University Itabashi Hospital Gastroenterological Surgery

    Itabashiku, Tokyo, 173-8610, Japan

  • Ogaki Municipal Hospital Gastroenterological Medicine

    Ōgaki, Gifu, 503-8502, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Osaka International Cancer Institute

    Osakashi, Osaka, 541-8567, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Osaka University Hospital

    Suitashi, Osaka, 565-0871, Japan

  • Osp Sbortolo, Ulss Berica

    Vicenza, 36100, Italy

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Po Di Cremona, Asst Di Cremona Oncologia Medica

    Cremona, 26100, Italy

  • Po Umberto I, Ao Ordine Mauriziano

    Torino, 10128, Italy

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138, Italy

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rj Zuckerberg Cancer Center

    Lake Success, New York, 11042, United States

  • Royal Free Hospital London Nhs Trust

    London, NW3 2QG, United Kingdom

  • Sasaki Foundation Kyoundo Hospital Hepatology

    Bunkyoku, Tokyo, 1138655, Japan

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong, 510000, China

  • Taichung Veterans General Hospital Gastroenterology

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Affiliated Hospital of Qingdao University Branch Laoshan

    Qingdao, Shandong, 266000, China

  • The Christie Hospital

    Greater Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 630014, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tottori University Hospital Multidisciplinary Internal Medicine

    Tottori, 683-8504, Japan

  • Tri Service General Hospital

    Taipei, 114, Taiwan

  • UCLA Hematologyoncology

    Los Angeles, California, 90095, United States

  • Ulssdolomiti

    Peschiera del Garda, 37019, Italy

  • Umdnj Njms

    Newark, New Jersey, 07840, United States

  • Uniklinik Koln (Aor)

    Cologne, 50937, Germany

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124, Italy

  • Universitaetsklinikum Leipzig Aor

    Leipzig, 04103, Germany

  • Universitatsklinikum Bonn

    Bonn, 53127, Germany

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225, Germany

  • University Hospital, Kyoto Prefectural Univ of Medicine

    Kyoto, 602-8566, Japan

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Ut Health San Antonio Mays Cancer Center

    San Antonio, Texas, 78229, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wakayama Medical University

    Wakayama, Wakayama, 641-8510, Japan

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000, China

  • Xcancerdayton Physician Network

    Dayton, Ohio, 45409, United States

  • Yokohama City University Medical Center Gastroenterological Center

    Yokohama, Kanagawa, 232-0024, Japan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Zhongnan Hospital of Wuhan University Wuhan

    Wuhan, Hubei, 430071, China

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