Evidence map›Paper›PMID 41293180›Full record

Trial reportFrontiers in immunology2025

Stereotactic body radiation therapy combined with cadonilimab and lenvatinib in the treatment of hepatocellular carcinoma with Vp3 or Vp4 portal vein tumor thrombus: a prospective, multicenter, single-arm, phase II clinical trial.

Ning Mo, Kai Hu, Zhiming Zeng, Lihua Yang, Yeying Fang, Jie Zeng, Ye Li, Zhendong Yang, Jing Tang, Tingting Zhang and 15 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06040177 (Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT06040177 phase1 / phase2unknown statusnot on this map

Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study

TypeinterventionalSponsorFirst Affiliated Hospital of Guangxi Medical UniversityRan2023 to 2025Enrolled30ConditionsHepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombus, Immune Checkpoint InhibitorsArmsCadonilimab, Stereotactic radiotherapy, Renvatinib
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. 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

25 authors.

Ning Mo *Department of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Kai Hu *Department of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Zhiming Zeng *Department of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Lihua YangDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Yeying FangDepartment of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Jie ZengDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Ye LiDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Zhendong YangDepartment of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Jing TangDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Tingting ZhangDepartment of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Fuchao MaDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Cuizhen LiuDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Haiping ZhengDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Jinfeng QiuDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Yanfeng JiangDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Yufeng LvDepartment of Oncology, Foresea Life Insurance Guangxi Hospital, Nanning, Guangxi, China.
Li LiangDepartment of Oncology, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Xiaofang HuangDepartment of Radiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Xiwen LiaoDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Yan WangMedical Center, Akeso Biopharma, Inc, Zhongshan, China.
Xiuyuan LuGuangxi Medical University, Nanning, Guangxi, China.
Lijun NingGuangxi Medical University, Nanning, Guangxi, China.
Shixue Lao GuoGuangxi Medical University, Nanning, Guangxi, China.
Jie MaDepartment of Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Rensheng WangDepartment of Radiotherapy, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Hepatocellular carcinoma (HCC) patients with portal vein tumor thrombus (PVTT) exhibit a dismal prognosis, occurring in 44%-62.2% of cases at initial diagnosis. The optimal treatment for this population remains undefined. Methods: In this prospective, multicenter, single-arm phase II trial across three Chinese centers, eligible HCC patients with Vp3/4 PVTT received combined stereotactic body radiotherapy (SBRT), cadonilimab, and lenvatinib. Primary endpoint was objective response rate (ORR) in primary liver lesions (RECIST v1.1/mRECIST); secondary endpoints included ORR in PVTT, progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. Results: Of 24 enrolled patients, 21 were evaluable for efficacy. ORR for primary lesions was 38.1% (RECIST v1.1) and 47.6% (mRECIST), with a disease control rate (DCR) of 100% by both criteria. For PVTT, ORR and DCR were 76.2% and 100%, respectively. At a median follow-up of 19.7 months, median PFS was 6.8 months (95% CI: 4.6-12.9), DOR was 10.4 months (95% CI: 2.9-NE), and OS was 13.4 months (95% CI: 6.8-NE). Early biomarker declines (≥75% AFP reduction or ≥50% PIVKA-II decline at 6 weeks) correlated with superior outcomes: AFP reduction predicted longer PFS (HR=0.22, p=0.006) and OS (HR=0.25, p=0.024); PIVKA-II reduction similarly predicted PFS (HR=0.28, p=0.007) and OS (HR=0.18, p=0.002). Common treatment-related adverse events (TRAEs) included hypertension (50%), thrombocytopenia (42%), and fatigue (38%). Conclusions: The combination of SBRT, cadonilimab, and lenvatinib showed promising efficacy and manageable toxicity in HCC patients with Vp3/4 PVTT. Early AFP or PIVKA-II response at 6 weeks may serve as a prognostic biomarker. Clinical Trial Registration: ClinicalTrials.gov, identifier NCT06040177.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularLiver NeoplasmsPhenylurea CompoundsPortal VeinQuinolinesRadiosurgeryVenous ThrombosisAdultAgedCombined Modality TherapyFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedlenvatinibPhenylurea CompoundsQuinolinescadonilimabhepatocellular carcinomalenvatinibportal vein tumor thrombusstereotactic body radiation therapy

Identifiers

PMID41293180
PMCPMC12640821

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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.