Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomized, prospective, multicentre, phase Ⅱ trial (TORCH-C)
| العنوان: | Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomized, prospective, multicentre, phase Ⅱ trial (TORCH-C) |
|---|---|
| المؤلفون: | Hui Zhang, Yaqi Li, Fan Xia, Yiqun Sun, Lijun Shen, Juefeng Wan, Yajie Chen, Yaqi Wang, Menglong Zhou, Ruiyan Wu, Shujuan Zhou, Yan Wang, Fangqi Liu, Sanjun Cai, Zhen Zhang |
| بيانات النشر: | Research Square Platform LLC, 2023. |
| سنة النشر: | 2023 |
| الوصف: | Background The preliminary result of the TORCH trial has showed promising complete response (CR) for managing locally advanced rectal cancer (LARC) with neoadjuvant short-couse radiotherapy (SCRT) combined with chemotherapy and PD-1 inhibitor. For locally advanced colon cancer (LACC) with bulky nodal disease and/or clinically T4, neoadjuvant chemotherapy followed by colectomy with en bloc removal of regional lymph nodes is the suggested treatment. However, the CR rate is less than 5%. TORCH-C will aim to investigate neoadjuvant short-couse radiotherapy combined with chemotherapy and PD-1 inhibitor in LACC.Methods TORCH-C is a randomized, prospective, multicentre, double-arm, open, phase Ⅱ trial of SCRT combined with chemotherapy and immunotherapy in LACC with microsatellite-stable (MSS) patients and cT4 or bulky nodes. Eligible patients will be identified by the multidisplinary team. 120 patients will be randomized 1:1 to the intervention or control arm. The patients in the control arm will receive 4 cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by 4 cycles of CAPOX and PD-1 inhibitor (Serplulimab). Both arms will receive curative surgery, followed by 4 cycles of CAPOX. The primary endpoint is pathologic complete regression (pCR).Discussion TORCH-C trial aims to investigate whether the combination of immunotherapy and chemoradiotherapy improves the treatment effect in LACC with MSS. TORCH-C will establish the TORCH platform, a key part of our long-term strategy to develop neoadjuvant treatment for colorectal cancer (CRC).Trial registration: The trial has been registered in ClinicalTrials.gov on Feburary 16, 2023 (Registration No. NCT05732493). |
| DOI: | 10.21203/rs.3.rs-2759620/v1 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::4e83d97e5aded378606dfaa601d8fcbf https://doi.org/10.21203/rs.3.rs-2759620/v1 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi...........4e83d97e5aded378606dfaa601d8fcbf |
| قاعدة البيانات: | OpenAIRE |
| ResultId |
1 |
|---|---|
| Header |
edsair OpenAIRE edsair.doi...........4e83d97e5aded378606dfaa601d8fcbf 894 3 unknown 894.317749023438 |
| PLink |
https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&scope=site&db=edsair&AN=edsair.doi...........4e83d97e5aded378606dfaa601d8fcbf&custid=s6537998&authtype=sso |
| FullText |
Array
(
[Availability] => 0
)
Array ( [0] => Array ( [Url] => https://explore.openaire.eu/search/publication?articleId=doi_________::4e83d97e5aded378606dfaa601d8fcbf# [Name] => EDS - OpenAIRE [Category] => fullText [Text] => View record in OpenAIRE [MouseOverText] => View record in OpenAIRE ) ) |
| Items |
Array
(
[Name] => Title
[Label] => Title
[Group] => Ti
[Data] => Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomized, prospective, multicentre, phase Ⅱ trial (TORCH-C)
)
Array ( [Name] => Author [Label] => Authors [Group] => Au [Data] => <searchLink fieldCode="AR" term="%22Hui+Zhang%22">Hui Zhang</searchLink><br /><searchLink fieldCode="AR" term="%22Yaqi+Li%22">Yaqi Li</searchLink><br /><searchLink fieldCode="AR" term="%22Fan+Xia%22">Fan Xia</searchLink><br /><searchLink fieldCode="AR" term="%22Yiqun+Sun%22">Yiqun Sun</searchLink><br /><searchLink fieldCode="AR" term="%22Lijun+Shen%22">Lijun Shen</searchLink><br /><searchLink fieldCode="AR" term="%22Juefeng+Wan%22">Juefeng Wan</searchLink><br /><searchLink fieldCode="AR" term="%22Yajie+Chen%22">Yajie Chen</searchLink><br /><searchLink fieldCode="AR" term="%22Yaqi+Wang%22">Yaqi Wang</searchLink><br /><searchLink fieldCode="AR" term="%22Menglong+Zhou%22">Menglong Zhou</searchLink><br /><searchLink fieldCode="AR" term="%22Ruiyan+Wu%22">Ruiyan Wu</searchLink><br /><searchLink fieldCode="AR" term="%22Shujuan+Zhou%22">Shujuan Zhou</searchLink><br /><searchLink fieldCode="AR" term="%22Yan+Wang%22">Yan Wang</searchLink><br /><searchLink fieldCode="AR" term="%22Fangqi+Liu%22">Fangqi Liu</searchLink><br /><searchLink fieldCode="AR" term="%22Sanjun+Cai%22">Sanjun Cai</searchLink><br /><searchLink fieldCode="AR" term="%22Zhen+Zhang%22">Zhen Zhang</searchLink> ) Array ( [Name] => Publisher [Label] => Publisher Information [Group] => PubInfo [Data] => Research Square Platform LLC, 2023. ) Array ( [Name] => DatePubCY [Label] => Publication Year [Group] => Date [Data] => 2023 ) Array ( [Name] => Abstract [Label] => Description [Group] => Ab [Data] => Background The preliminary result of the TORCH trial has showed promising complete response (CR) for managing locally advanced rectal cancer (LARC) with neoadjuvant short-couse radiotherapy (SCRT) combined with chemotherapy and PD-1 inhibitor. For locally advanced colon cancer (LACC) with bulky nodal disease and/or clinically T4, neoadjuvant chemotherapy followed by colectomy with en bloc removal of regional lymph nodes is the suggested treatment. However, the CR rate is less than 5%. TORCH-C will aim to investigate neoadjuvant short-couse radiotherapy combined with chemotherapy and PD-1 inhibitor in LACC.Methods TORCH-C is a randomized, prospective, multicentre, double-arm, open, phase Ⅱ trial of SCRT combined with chemotherapy and immunotherapy in LACC with microsatellite-stable (MSS) patients and cT4 or bulky nodes. Eligible patients will be identified by the multidisplinary team. 120 patients will be randomized 1:1 to the intervention or control arm. The patients in the control arm will receive 4 cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by 4 cycles of CAPOX and PD-1 inhibitor (Serplulimab). Both arms will receive curative surgery, followed by 4 cycles of CAPOX. The primary endpoint is pathologic complete regression (pCR).Discussion TORCH-C trial aims to investigate whether the combination of immunotherapy and chemoradiotherapy improves the treatment effect in LACC with MSS. TORCH-C will establish the TORCH platform, a key part of our long-term strategy to develop neoadjuvant treatment for colorectal cancer (CRC).Trial registration: The trial has been registered in ClinicalTrials.gov on Feburary 16, 2023 (Registration No. NCT05732493). ) Array ( [Name] => DOI [Label] => DOI [Group] => ID [Data] => 10.21203/rs.3.rs-2759620/v1 ) Array ( [Name] => URL [Label] => Access URL [Group] => URL [Data] => <link linkTarget="URL" linkTerm="https://explore.openaire.eu/search/publication?articleId=doi_________::4e83d97e5aded378606dfaa601d8fcbf" linkWindow="_blank">https://explore.openaire.eu/search/publication?articleId=doi_________::4e83d97e5aded378606dfaa601d8fcbf</link><br /><link linkTarget="URL" linkTerm="https://doi.org/10.21203/rs.3.rs-2759620/v1" linkWindow="_blank">https://doi.org/10.21203/rs.3.rs-2759620/v1</link> ) Array ( [Name] => Copyright [Label] => Rights [Group] => Cpyrght [Data] => OPEN ) Array ( [Name] => AN [Label] => Accession Number [Group] => ID [Data] => edsair.doi...........4e83d97e5aded378606dfaa601d8fcbf ) |
| RecordInfo |
Array
(
[BibEntity] => Array
(
[Identifiers] => Array
(
[0] => Array
(
[Type] => doi
[Value] => 10.21203/rs.3.rs-2759620/v1
)
)
[Languages] => Array
(
[0] => Array
(
[Text] => Undetermined
)
)
[Titles] => Array
(
[0] => Array
(
[TitleFull] => Study protocol of short-course radiotherapy combined with CAPOX and PD-1 inhibitor for locally advanced colon cancer: a randomized, prospective, multicentre, phase Ⅱ trial (TORCH-C)
[Type] => main
)
)
)
[BibRelationships] => Array
(
[HasContributorRelationships] => Array
(
[0] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Hui Zhang
)
)
)
[1] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Yaqi Li
)
)
)
[2] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Fan Xia
)
)
)
[3] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Yiqun Sun
)
)
)
[4] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Lijun Shen
)
)
)
[5] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Juefeng Wan
)
)
)
[6] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Yajie Chen
)
)
)
[7] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Yaqi Wang
)
)
)
[8] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Menglong Zhou
)
)
)
[9] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Ruiyan Wu
)
)
)
[10] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Shujuan Zhou
)
)
)
[11] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Yan Wang
)
)
)
[12] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Fangqi Liu
)
)
)
[13] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Sanjun Cai
)
)
)
[14] => Array
(
[PersonEntity] => Array
(
[Name] => Array
(
[NameFull] => Zhen Zhang
)
)
)
)
[IsPartOfRelationships] => Array
(
[0] => Array
(
[BibEntity] => Array
(
[Dates] => Array
(
[0] => Array
(
[D] => 18
[M] => 04
[Type] => published
[Y] => 2023
)
)
[Identifiers] => Array
(
[0] => Array
(
[Type] => issn-locals
[Value] => edsair
)
[1] => Array
(
[Type] => issn-locals
[Value] => edsairFT
)
)
)
)
)
)
)
|
| IllustrationInfo |