Evidence map›Paper›PMID 36521893›Full record

ArticleBMJ open2022

Efficacy and safety of radiotherapy combined with atezolizumab plus bevacizumab in treating hepatocellular carcinoma with portal vein tumour thrombus: a study protocol.

Kang Wang, Hong-Ming Yu, Yan-Jun Xiang, Yu-Qiang Cheng, Qian-Zhi Ni, Wei-Xing Guo, Jie Shi, Shuang Feng, Jian Zhai, Shu-Qun Cheng

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Kang WangDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Hong-Ming YuDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Yan-Jun XiangDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Yu-Qiang ChengDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Qian-Zhi NiDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Wei-Xing GuoDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Jie ShiDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Shuang FengDepartment of Radiotherapy, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Jian ZhaiDepartment of Radiotherapy, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
Shu-Qun ChengDepartment of Hepatic Surgery VI, Eastern Hepatobiliary Surgery Hospital, Shanghai, China chengshuqun@smmu.edu.cn.ORCID 0000-0002-6098-8028
Second Military Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVascular invasion and metastasis are poor prognostic factors in patients with hepatocellular carcinoma (HCC). The efficacy of available therapeutic regimens for unresectable HCC is not satisfactory in HCC with portal vein tumour thrombosis (PVTT). Therefore, this open-label, single-arm phase II clinical trial aims to investigate the efficacy and safety of radiotherapy combined with atezolizumab plus bevacizumab in treating HCC patients with PVTT. METHODS AND ANALYSIS: We plan to enrol patients diagnosed with unresectable HCC complicated by PVTT. Intensity-modulated radiotherapy (IMRT) combined with atezolizumab plus bevacizumab will be administered for treatment. Patients will initially receive radiotherapy, with each IMRT cycle lasting for 28 days and the total dose of tumour (DT) of 40 Gy/20 f/26 d. CT scan will be performed again, and the treatment plan will be reformulated after field constriction. The treatment will continue until the total DT is up to 54-56 Gy/27-28 f. The treatment with atezolizumab plus bevacizumab will be started at 3±1 days after the initiation of radiotherapy and will continue until unacceptable toxicity or disease progression. The primary endpoint is objective response rate (ORR), while the secondary endpoints include overall survival, disease control rate, progression-free survival, time to progression, duration of response and the rate of surgical conversions. Assuming an ORR of 47%, with a two-sided alpha error of 0.1, 90% power, and a 10% drop-out rate, the required number of evaluable patients is 42. ETHICS AND DISSEMINATION: This study will be conducted according to the standards of Good Clinical Practice and in compliance with the principles of the Declaration of Helsinki. The Ethics Committee of our Hospital has approved the protocol (EHBHKY2021-K-017). All participants are required to provide written informed consent. The results of the trial will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2100049831.

Indexed as

Carcinoma, HepatocellularLiver NeoplasmsVenous ThrombosisAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabHumansPortal VeinAntibodies, Monoclonal, HumanizedatezolizumabBevacizumabAdult oncologyHepatobiliary tumoursRADIOTHERAPY

Identifiers

PMID36521893
PMCPMC9756192
OpenAlexW4311549444

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.