Evidence map›Paper›PMID 36872927›Full record

ArticleLiver cancer2023

Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial.

Zhenggang Ren, Michel Ducreux, Ghassan K Abou-Alfa, Philippe Merle, Weijia Fang, Julien Edeline, Zhiwei Li, Lihua Wu, Eric Assenat, Sheng Hu and 20 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Liver cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03419897 (A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma), which is not on this map. Cited by 56 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 3 pooled it
7.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03419897 phase2completednot on this map

A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma

TypeinterventionalSponsorBeiGeneRan2018 to 2022Enrolled249ConditionsHepatocellular Carcinoma (HCC)ArmsTislelizumab
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. [Chinese expert consensus on the use of standardized second-line drugs for primary hepatocellular carcinoma].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 20 institutions in 6 countries.

Zhenggang RenDepartment of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, and Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, Shanghai, China.
Michel DucreuxMedical Oncology Department, Gustave Roussy, INSERM U1279, Paris-Saclay University, Villejuif, France.
Ghassan K Abou-AlfaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, and Weill Medical College at Cornell University, New York, New York, USA.
Philippe MerleDepartment of Hepatology, Hospital La Croix-Rousse, Lyon, France.
Weijia FangDepartment of Medical Oncology, The First Affiliated Hospital Zhejiang University, Hangzhou, China.
Julien EdelineDepartment of Medical Oncology, Centre Eugène Marquis, Rennes, France, and ARPEGO (Accès à La Recherche Précoce Dans Le Grand-Ouest) Network, Rennes, France.
Zhiwei LiDivision of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Lihua WuDivision of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.
Eric AssenatDepartment of Oncology, CHRU Saint Eloi, Montpellier, France.
Sheng HuDepartment of Internal Medicine-Oncology, Hubei Cancer Hospital, Wuhan, China.
Lorenza RimassaMedical Oncology and Hematology Unit, Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), Italy, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Tao ZhangAbdominal Oncology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jean-Frédéric BlancService Hépato-Gastroentérologie et Oncologie Digestive, Groupe Hospitalier Sud - Hôpital Haut Lévêque, Bordeaux, France.
Hongming PanDepartment of Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, China.
Paul RossDepartment of Gastroenterology, Guy's and St Thomas' NHS Foundation Trust and Department of Oncology, King's College Hospital NHS Foundation Trust, London, UK.
Chia-Jui YenDivision of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
Albert TranDépartement Digestif, Université Côte d'Azur, Nice, France, and Centre Hospitalier Universitaire de Nice, Nice, France, and Centre Méditerranéen de Médecine Moléculaire, INSERUM U1065, Université Côte d'Azur, Nice, France.
Guoliang ShaoDepartment of Radiology, Zhejiang Cancer Hospital, Hangzhou, China.
Mohamed BouattourDepartment of Digestive Oncology, APHP Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, Clichy, France.
Yajin ChenDepartment of Hepatobiliary Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Tim MeyerAcademic Department of Oncology, Royal Free Hospital NHS Trust, Pond Street, London, UK.
Jinlin HouState Key Laboratory of Organ Failure Research, Guangdong Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.
David TougeronGastroenterology and Hepatology Department, University of Poitiers and Department of Gastroenterology and Hepatology, Poitiers University Hospital, Poitiers, France.
Yuxian BaiDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Ming-Mo HouDepartment of Oncology, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
Zhiqiang MengDepartment of Integrative Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
John WuBiostatistics, BeiGene USA, Inc., Ridgefield Park, New Jersey, USA.
Vincent LiClinical Development, BeiGene (Beijing) Co., Ltd., Beijing, China.
Sandra Chica-DuqueClinical Development, BeiGene USA, Inc., San Mateo, California, USA.
Ann-Lii ChengDepartment of Oncology, National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.
First Affiliated Hospital Zhejiang University · CNBeiGene (China) · CNCentre Eugène Marquis · FRChang Gung University · TWDeltagen (United States) · USFudan University · CNFudan University Shanghai Cancer Center · CNGuy's and St Thomas' NHS Foundation Trust · GBHarbin Medical University · CNHôpital Beaujon · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital de la Croix-Rousse · FRHôpital Saint Eloi · FRHubei Cancer Hospital · CNHumanitas University · ITInserm · FRMemorial Sloan Kettering Cancer Center · USNanfang Hospital · CNNational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TW

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Introduction: Tislelizumab (anti-programmed cell death protein 1 antibody) showed preliminary antitumor activity and tolerability in patients with advanced solid tumors, including hepatocellular carcinoma (HCC). This study aimed to assess the efficacy and safety of tislelizumab in patients with previously treated advanced HCC. Methods: The multiregional phase 2 study RATIONALE-208 examined single-agent tislelizumab (200 mg intravenously every 3 weeks) in patients with advanced HCC with Child-Pugh A, Barcelona Clinic Liver Cancer stage B or C, and who had received one or more prior lines of systemic therapy. The primary endpoint was objective response rate (ORR), radiologically confirmed per Response Evaluation Criteria in Solid Tumors version 1.1 by the Independent Review Committee. Safety was assessed in patients who received ≥1 dose of tislelizumab. Results: Between April 9, 2018, and February 27, 2019, 249 eligible patients were enrolled and treated. After a median study follow-up of 12.7 months, ORR was 13% ( Conclusion: Tislelizumab demonstrated durable objective responses, regardless of the number of prior lines of therapy, and acceptable tolerability in patients with previously treated advanced HCC.

Indexed as

Hepatocellular carcinomaImmunotherapyPretreated patient populationTislelizumab

Identifiers

PMID36872927
PMCPMC9982342
OpenAlexW4301187746

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.