Evidence map›Paper›PMID 38205914›Full record

ArticleCancer medicine2024

A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma.

Jiyi Hu, Qingting Huang, Weixu Hu, Jing Gao, Jing Yang, Haojiong Zhang, Jiade Jay Lu, Lin Kong

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  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

8 authors at 2 institutions in 2 countries.

Jiyi HuDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Qingting HuangDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.ORCID 0000-0002-9488-5983
Weixu HuDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Jing GaoDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Jing YangDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Haojiong ZhangDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Jiade Jay LuDepartment of Radiation Oncology, Proton and Heavy Ion Center, Heyou International Hospital, Foshan, China.
Lin KongDepartment of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
Fudan University Shanghai Cancer Center · CNHeavitree Hospital · GB

Funding

Shanghai Municipal Health Commission Clinical research project 202340150the Key research and development Program of the Ministry of Science and Technology 2022YFC2401505the Science and Technology Development Fund of Shanghai Pudong New Area PKJ2022-Y53
6 · The paper itself

Abstract

purposeManagement of locoregionally recurrent nasopharyngeal carcinoma (LR NPC) is difficult. Although carbon-ion radiation therapy (CIRT) could substantially improve the overall survival (OS) of those patients, around 40% of the patients may still develop local failure. Further improvement of the disease control is necessary. Immunotherapy, such as immune checkpoint inhibitors (ICIs) becomes a promising antitumor treatment. The role of ICIs was proved in head and neck cancers including recurrent/metastatic NPC. Preclinical studies indicated potential synergistic effects between radiation therapy and ICIs. Therefore, we conduct a randomized phase 2 trial to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 monoclonal antibody, along with CIRT in patients with LR NPC.

methodsPatients will be randomly assigned at 1:1 to receive either standard CIRT with 63 Gy (relatively biological effectiveness, [RBE]) in 21 fractions, or standard CIRT plus concurrent camrelizumab. Camrelizumab will be administered intravenously with a dose of 200 mg, every 2 week, for a maximum of 1 year. We estimate addition of camrelizumab will improve the 2-year progression-free survival (PFS) from 45% to 60%. A total of 146 patients (with a 5% lost to follow-up rate) is required to yield a type I error of 0.2, and a power of 0.8. RESULTS AND

conclusionThe results of the trial may shed insights on the combined therapy with ICIs and CIRT.

Indexed as

Antibodies, Monoclonal, HumanizedHeavy Ion RadiotherapyNasopharyngeal NeoplasmsCarbonClinical Trials, Phase II as TopicHumansImmune Checkpoint InhibitorsNasopharyngeal CarcinomaRandomized Controlled Trials as TopicAntibodies, Monoclonal, HumanizedcamrelizumabCarbonImmune Checkpoint Inhibitorscamrelizumabcarbon ionradiotherapy (RT)randomized trialrecurrent nasopharyngeal carcinoma

Identifiers

PMID38205914
PMCPMC10905325
OpenAlexW4390740828

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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.