Evidence map›Paper›PMID 42091859›Full record

Trial reportSignal transduction and targeted therapy2026

Sintilimab (PD-1 inhibitor) plus lenvatinib as conversion therapy followed by sequential surgery (SILENSES) for advanced unresectable hepatocellular carcinoma: a phase II, expansion trial.

Shichun Lu, Wenwen Zhang, Junfeng Li, Ze Zhang, Bingyang Hu, Xuerui Li, Yinbiao Cao, Zhijun Wang, Zhanbo Wang, Huiyi Ye and 14 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Signal transduction and targeted therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

24 authors.

Shichun Lu *Senior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China. lusc_301@163.com.ORCID http://orcid.org/0009-0003-7444-734X
Wenwen Zhang *Senior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Junfeng Li *Senior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Ze Zhang *Senior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Bingyang HuDepartment of General Surgery, Beijing Shijingshan Hospital, Beijing, China.
Xuerui LiSchool of Medicine, Nankai University, Tianjin, China.
Yinbiao CaoSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Zhijun WangDivision of Interventional Radiology, Department of Geriatric Medicine & National Clinical Research Center of Geriatric Disease, the 2nd Medical Center of Chinese PLA General Hospital, Beijing, China.
Zhanbo WangDepartment of pathology, Chinese PLA General Hospital, Beijing, China.
Huiyi YeDepartment of Radiology, Chinese PLA General Hospital, Beijing, China.
Baolin QuDepartment of Radiation Oncology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.
Yu LiDepartment of Radiation Oncology, the First Medical Center of Chinese PLA General Hospital, Beijing, China.
Guangyu MaDepartment of Nuclear Medicine, Chinese PLA General Hospital, Beijing, China.
Tao WanSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Zhe LiuSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Bing LiuSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Yinzhe XuSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Haowen TangSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Xiao ZhaoDepartment of Clinical Oncology, The Fifth Medical Centre, Chinese PLA General Hospital, Beijing, China.
Liru PanSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Li YangSenior Department of Faculty of Hepato-Pancreato-Biliary Surgery, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Jing YuanDepartment of pathology, Chinese PLA General Hospital, Beijing, China.
Ruiqing ChenDivision of Interventional Radiology, Department of Geriatric Medicine & National Clinical Research Center of Geriatric Disease, the 2nd Medical Center of Chinese PLA General Hospital, Beijing, China.
Xiangbing BianDepartment of Radiology, Chinese PLA General Hospital, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our previous findings demonstrated the promising antitumor activity and manageable safety of sintilimab-lenvatinib conversion therapy. The current study aimed to evaluate long-term survival outcomes in patients with unresectable hepatocellular carcinoma (HCC) who underwent sequential surgical resection after successful conversion therapy. In this prospective, single-arm, expansion, phase II trial, patients with unresectable HCC received lenvatinib plus sintilimab conversion therapy. Hepatectomy was performed in consenting patients after successful conversion therapy. The primary endpoint was the conversion rate; secondary endpoints included median overall survival (OS), 5-year survival rates, and recurrence-free survival (RFS). Successful conversion was achieved in 67 of 120 patients (56%, 67/120). Independent imaging review per mRECIST and RECIST v1.1 criteria demonstrated objective response rates of 58.3% (70/120) and 45.8% (55/120), respectively. With a median follow-up of 41.0 months (95% confidence interval [CI], 39.5-42.5) for the entire cohort, the median OS was 36.0 months (95% CI, 25.0 to not estimable [NE]), with a 5-year OS rate of 42.6% (95% CI, 34.0-53.0). Following multidisciplinary team evaluation and consideration of patient preferences, 60 patients underwent surgical resection, achieving a median RFS of 40.0 months (95% CI, 24.0 to NE) and a 5-year survival rate of 73.9% (95% CI, 62.7-87.1). Grade ≥3 treatment-related adverse events occurred in 37 patients (31%). Approximately half of the patients with unresectable HCC achieved successful conversion after sintilimab plus lenvatinib therapy. Among those who achieved successful conversion, subsequent curative surgery demonstrated not only a favorable safety profile but also significant survival benefits. Trial registration number: ChiCTR1900023914.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsPhenylurea CompoundsQuinolinesAdultAgedFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedlenvatinibPhenylurea CompoundsQuinolinessintilimab

Identifiers

PMID42091859
PMCPMC13149660

What OpenQuestion holds

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Registered trials

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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.