New drug cocktail aims to stop liver cancer recurrence after surgery
NCT ID NCT04102098
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a combination of two drugs (atezolizumab and bevacizumab) can prevent liver cancer from returning in people who had surgery or ablation to remove their tumor. About 668 participants at high risk of recurrence were randomly assigned to receive the drug combination or just be monitored. The main goal was to see how long people stayed cancer-free.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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668 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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May 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: * Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only) within 4-12 weeks prior to randomization * Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only) * Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread * Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure * Full recovery from surgical resection or ablation within 4 weeks prior to randomization * High risk for HCC recurrence after resection or ablation * For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization * For patients with resected HCC, availability of a representative baseline tumor tissue sample * ECOG Performance Status of 0 or 1 * Child-Pugh Class A status * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Evidence of residual, recurrent, or metastatic disease at randomization * Clinically significant ascites * History of hepatic encephalopathy * Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization * Have received more than 1 cycle of adjuvant TACE following surgical resection * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina * History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Active tuberculosis * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications * Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1. * Co-infection with HBV and HCV * Co-infection with HBV and hepatitis D viral infection * Clinical significant uncontrolled or symptomatic hypercalcemia * Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE * Treatment with systemic immunostimulatory or immunosuppressive agents * Inadequately controlled arterial hypertension * History of hypertensive crisis or hypertensive encephalopathy * Significant vascular disease * Evidence of bleeding diathesis or significant coagulopathy * Current or recent use of aspirin or full-dose oral or parenteral anticoagulants * Core biopsy within 3 days of Day 1 of Cycle 1 * History of GI fistula, GI perforation, or intra-abdominal abscess * Serious non-healing or dehiscing wound * Major surgical procedure within four weeks * Chronic daily treatment with a non-steroidal anti-inflammatory drug
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Delta (Campus Rumbeke)
Roeselare, 8800, Belgium
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Adana Baskent University Hospital
Adana, 01120, Turkey (Türkiye)
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Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
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Ajou University Medical Center
Gyeonggi-do, 16499, South Korea
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Anhui Province Cancer Hospital
Hefei, 12345, China
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Anhui Provincial Hospital
Anhui, 230001, China
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Asan Medical Center
Seoul, 05505, South Korea
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Asst Santi Paolo E Carlo
Milan, Lombardy, 20142, Italy
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Auckland City Hospital
Auckland, 1023, New Zealand
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Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, 56100, Italy
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Beijing Cancer Hospital
Beijing, 100142, China
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Boramae Medical Center
Seoul, 07061, South Korea
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CHA Bundang Medical Center
Gyeonggi-do, 13496, South Korea
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CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, France
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CHU de Toulouse - Hôpital Rangueil
Toulouse, 31059, France
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Cancer Center of Guangzhou Medical University
Guangzhou, 510000, China
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Chang Gung Medical Foundation - Linkou
Taoyuan, 333, Taiwan
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Changhua Christian Hospital
Chang-hua, 500, Taiwan
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Chiang Rai Prachanukroh Hospital
Chiang Rai, 57000, Thailand
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Chiba University Hospital
Chiba, 260-8677, Japan
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Chulabhorn Hospital
Lak Si, 10210, Thailand
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Clinica CIMCA
San José, 10103, Costa Rica
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Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency
Nizhny Novgorod, Niznij Novgorod, 603109, Russia
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Clínica San Gabriel
Lima, 15088, Peru
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Columbia University Medical Center
New York, New York, 10032, United States
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Daping Hospital of Third Military Medical University
Chongqing, 400042, China
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Ehime Prefectural Central Hospital
Ehime, 790-0024, Japan
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Fakultni Thomayerova Nemocnice
Prague, 140 59, Czechia
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Fakultni nemocnice Brno
Brno, 625 00, Czechia
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Filios Alta Medicina
Monterrey, Nuevo León, 64460, Mexico
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First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Moscow Oblast, 119991, Russia
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Fondation Hopital Saint Joseph
Marseille, 13285, France
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Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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Fujian Cancer Hospital
Fuzhou, 350014, China
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Gangnam Severance Hospital
Seoul, 06273, South Korea
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Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
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Group of companies "Medci"
Moskva, Moscow Oblast, 105229, Russia
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Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
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Harbin Medical University Cancer Hospital
Harbin, 150081, China
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Hiroshima University Hospital
Hiroshima, 734-8551, Japan
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Hopital Jean Minoz
Besançon, 25030, France
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Hopital Robert Debre
Reims, 51092, France
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Hopital de Pontchaillou
Rennes, 35033, France
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Hopitaux de Brabois - Gastro-Entereologie
Vandœuvre-lès-Nancy, 54511, France
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Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-020, Brazil
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Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
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Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
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Hospital Universitario Infanta Cristina
Badajoz, 06080, Spain
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Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
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Hospital do Cancer UOPECCAN
Cascavel, Paraná, 85806-300, Brazil
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Huashan Hospital Affiliated to Fudan University
Shanghai, 200040, China
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Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
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Hôpital Albert Michallon
La Tronche, 38700, France
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Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis
Bobigny, 93009, France
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Imeldaziekenhuis
Bonheiden, 2820, Belgium
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Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038, Peru
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Japanese Red Cross Musashino Hospital
Tokyo, 180-8610, Japan
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Japanese Red Cross Society Himeji Hospital
Hyōgo, 670-8540, Japan
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Kaiser Permanente Los Angeles
Los Angeles, California, 90027, United States
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Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
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Kanazawa University Hospital
Ishikawa, 920-8641, Japan
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
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Kindai University Hospital
Osaka, 589-8511, Japan
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Kitasato University Hospital
Kanagawa, 252-0375, Japan
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Klinik Johann Wolfgang von Goethe Uni
Frankfurt am Main, 60590, Germany
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Klinikum Klagenfurt am Wörtersee
Klagenfurt, 9020, Austria
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Klinikum der Uni Regensburg
Regensburg, 93053, Germany
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Kumamoto University Hospital
Kumamoto, 860-8556, Japan
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Kyungpook National University Hospital
Daegu, 41944, South Korea
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Lkh-Univ. Klinikum Graz
Graz, 8036, Austria
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
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McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1, Canada
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Medizinische Universität Wien
Vienna, 1090, Austria
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Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, 350025, China
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Mercy Medical Center
Baltimore, Maryland, 21202, United States
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Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
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Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210029, China
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Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, 02-034, Poland
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National Cancer Centre
Singapore, 168583, Singapore
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National Taiwan Uni Hospital
Taipei, 100, Taiwan
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Northern Jangsu People's Hospital
Yangzhou, China
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Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
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Osaka Red Cross Hospital
Osaka, 543-8555, Japan
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Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
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Ospedale Regionale Di Parma
Parma, Emilia-Romagna, 43100, Italy
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Peking Union Medical College Hospital
Beijing, 100730, China
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Prince of Wales Hospital
Shatin, Hong Kong
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Pusan National University Hospital
Busan, 49241, South Korea
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Queen Mary Hospital
Hong Kong, Hong Kong
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Rajavithi Hospital
Bangkok, 10400, Thailand
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Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
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Renmin Hospital of Wuhan University
Wuhan, 430060, China
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Russian Scientific Center of Radiology and Surgical Technologies
Pesochny, Sankt-Peterburg, 197758, Russia
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Samsung Medical Center
Seoul, 6351, South Korea
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Sapporo Kosei General Hospital
Hokkaido, 060-0033, Japan
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Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
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Seoul National University Hospital
Seoul, 03080, South Korea
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Seoul St Mary's Hospital
Seoul, 06591, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
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Shandong Cancer Hospital
Jinan, 250117, China
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Shengjing Hospital of China Medical University
Shenyang, 110004, China
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Siriraj Hospital
Bangkok, 10700, Thailand
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Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasília, Federal District, 70200-730, Brazil
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St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
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Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
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Swedish Cancer Inst.
Seattle, Washington, 98104, United States
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Taipei Veterans General Hospital
Taipei, 112, Taiwan
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Tan Tock Seng Hospital
Singapore, 308433, Singapore
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The 81st Hospital of P.L.A.
Nanjing, 210002, China
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The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
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The First Affiliated Hospital of China Medical University
Shenyang, 110001, China
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The First Hospital of Jilin University
Changchun, 130021, China
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The Second Affiliated Hospital of Anhui Medical University
Hefei, 230601, China
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The Second Affiliated Hospital of Dalian Medical University
Dalian, 116027, China
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The Tumor Hospital of Xinjiang Medical University
Ürümqi, 830000, China
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The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
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The University of Tokyo Hospital
Tokyo, 113-8655, Japan
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Tianjin Cancer Hospital
Tianjin, 300060, China
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Tokushima University Hospital
Tokushima, 770-8503, Japan
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Toranomon Hospital
Tokyo, 105-8470, Japan
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Ulsan University Hosiptal
Ulsan, 44033, South Korea
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Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.
Bonn, 53127, Germany
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Universitätsklinikum Ulm
Ulm, 89081, Germany
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West China Hospital, Sichuan University
Chengdu, 610041, China
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Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
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Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
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Zhejiang Cancer Hospital
Hangzhou, 310022, China
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Zhongda Hospital Affiliated to Southeast University
Nanjing, 210009, China
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Zhongnan Hospital of Wuhan University
Wuhan, 430071, China
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Zhongshan Hospital Fudan Unvierstiy
Shanghai, China
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Zhujiang Hospital, Southern Medical University
Guangzhou, 510280, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New blood panel aims to catch liver cancer before it spreads
- Can a simple belly press make liver cancer radiation more precise?
- A new way to read CT scans may predict which liver surgery patients will develop Life-Threatening failure
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- New combo therapy aims to stop liver cancer from coming back
- Modified virus injected into tumors shows promise for liver cancer