Evidence map›Paper›PMID 38242982›Full record

Trial reportNature medicine2024

Adjuvant sintilimab in resected high-risk hepatocellular carcinoma: a randomized, controlled, phase 2 trial.

Kang Wang, Yan-Jun Xiang, Hong-Ming Yu, Yu-Qiang Cheng, Zong-Han Liu, Ying-Yi Qin, Jie Shi, Wei-Xing Guo, Chong-De Lu, Ya-Xin Zheng and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06313190 (Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma), which is not on this map. Cited by 87 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 5 pooled it
40.6field-weighted citation impact, top 1% 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.

NCT06313190 phase2recruitingnot on this map

Stereotactic Body Radiotherapy With or Without Adjuvant Immunotherapy for Small Hepatocellular Carcinoma: An Open-label, Randomized, Phase II Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2024 to 2030Enrolled140ConditionsHepatocellular CarcinomaArmsStereotactic body radiotherapy, Sintilimab
3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 5 syntheses or guidelines pooled it, 110 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

27 more citing papers are in PubMed but not listed here.

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

20 authors at 9 institutions in 3 countries.

Kang Wang *Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Yan-Jun Xiang *Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.ORCID 0000-0002-7378-6724
Hong-Ming Yu *Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Yu-Qiang Cheng *Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Zong-Han Liu *Department of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Ying-Yi QinDepartment of Health Statistics, Naval Medical University, Shanghai, China.
Jie ShiDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Wei-Xing GuoDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Chong-De LuDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Ya-Xin ZhengDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Fei-Guo ZhouDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
Mao-Lin YanDepartment of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital, Fuzhou, China.
Hong-Kun ZhouDepartment of Hepatobiliary and Pancreatic Surgery, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing College, Jiaxing, China.
Chao LiangDepartment of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Fan ZhangDepartment of Hepatobiliary Surgery, Affiliated Hospital of Binzhou Medical College, Binzhou, China.
Wen-Jing WeiDepartment of General Surgery, Taiyuan People's Hospital, Taiyuan, China.
Wan Yee LauFaculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.
Jing-Jing LiCAS Key Laboratory of Nutrition, Metabolism and Food Safety, Shanghai Institute of Nutrition and Health, University of Chinese Academy of Sciences, Chinese Academy of Sciences, Shanghai, China.ORCID 0000-0002-3973-5405
Yan-Fang LiuNational Key Laboratory of Medical Immunology, Institute of Immunology, Naval Medical University, Shanghai, China. liuyanfang00215@163.com.ORCID 0000-0002-2923-0729
Shu-Qun ChengDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China. chengshuqun@aliyun.com.ORCID 0000-0001-6760-7470
Second Military Medical University · CNBinzhou Medical University · CNChinese University of Hong Kong · HKFirst Hospital of Jiaxing · CNFourth People's Hospital of Taiyuan · CNFujian Provincial Hospital · CNNaval Medical Research Command · USShanghai Institute of Nutrition and Health · CNShanghai University of Traditional Chinese Medicine · CN

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82072618
6 · The paper itself

Abstract

Hepatocellular carcinoma (HCC), particularly when accompanied by microvascular invasion (MVI), has a markedly high risk of recurrence after liver resection. Adjuvant immunotherapy is considered a promising avenue. This multicenter, open-label, randomized, controlled, phase 2 trial was conducted at six hospitals in China to assess the efficacy and safety of adjuvant sintilimab, a programmed cell death protein 1 inhibitor, in these patients. Eligible patients with HCC with MVI were randomized (1:1) into the sintilimab or active surveillance group. The sintilimab group received intravenous injections every 3 weeks for a total of eight cycles. The primary endpoint was recurrence-free survival (RFS) in the intention-to-treat population. Key secondary endpoints included overall survival (OS) and safety. From September 1, 2020, to April 23, 2022, a total of 198 eligible patients were randomly allocated to receive adjuvant sintilimab (n = 99) or undergo active surveillance (n = 99). After a median follow-up of 23.3 months, the trial met the prespecified endpoints. Sintilimab significantly prolonged RFS compared to active surveillance (median RFS, 27.7 versus 15.5 months; hazard ratio 0.534, 95% confidence interval 0.360-0.792; P = 0.002). Further follow-up is needed to confirm the difference in OS. In the sintilimab group, 12.4% of patients experienced grade 3 or 4 treatment-related adverse events, the most common of which were elevated alanine aminotransferase levels (5.2%) and anemia (4.1%). These findings support the potential of immune checkpoint inhibitors as effective adjuvant therapy for these high-risk patients. Chinese Clinical Trial Registry identifier: ChiCTR2000037655 .

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsAdjuvants, ImmunologicAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansAdjuvants, ImmunologicAntibodies, Monoclonal, Humanizedsintilimab

Identifiers

PMID38242982
OpenAlexW4391027452

What OpenQuestion holds

Textmetadata
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.