Evidence map›Paper›PMID 39385104›Full record

ArticleBMC cancer2024

Node-sparing modified short-course Radiotherapy Combined with CAPOX and Tislelizumab for locally Advanced MSS of Middle and low rectal Cancer (mRCAT): an open-label, single-arm, prospective, multicentre clinical trial.

Cheng Cai, Xia Zhang, Xiaonan Sun, Huogang Wang, Engeng Chen, Li Chen, Benxing Gu, Jianping Wang, Xuefeng Huang, Weifeng Lao and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05972655 (Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer), 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.

NCT05972655 phase2recruitingnot on this map

Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial

TypeinterventionalSponsorSir Run Run Shaw HospitalRan2023 to 2026Enrolled32ConditionsLow Rectal CancerArmsModified short-course radiotherapy, PD-1 antibody, Capecitabine, Oxaliplatin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
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

15 authors.

Cheng Cai *Department of Colorectal and Anal Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Xia Zhang *Department of Oncology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Xiaonan SunDepartment of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Huogang WangDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Engeng ChenDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Li ChenDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Benxing GuDepartment of Radiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jianping WangDepartment of Colorectal and Anal Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Xuefeng HuangDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Weifeng LaoDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xiaowei WangDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Min ChenDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Shubo DingDepartment of Radiology, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Jinlin DuDepartment of Colorectal and Anal Surgery, Affiliated Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China. djl9090@163.com.
Zhangfa SongDepartment of Colorectal Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. songzhangfa@zju.edu.cn.

Funding

Major Project of Social Development of Jinhua Science and Technology Project 2023-3-100National Natural Science Foundation of China 82273265Zhejiang Committee of Science and Technology GZY-ZJ-KJ-23029
6 · The paper itself

Abstract

backgroundNeoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer. Mismatch repair-deficient locally advanced rectal cancer (LARC) was highly sensitive to PD-1 blockade. However, most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) subtypes for which PD-1 blockade is ineffective. Radiation can trigger the activation of CD8 + T cells, further enhancing the responses of MSS/pMMR rectal cancer to PD-1 blockade. Radioimmunotherapy offers a promising therapeutic modality for rectal cancer. Progenitor T exhausted cells are abundant in tumour-draining lymph nodes and play an important role in immunotherapy. Conventional irradiation fields include the mesorectum and regional lymph nodes, which might cause considerable damage to T lymphocytes and radiation-induced fibrosis, ultimately leading to a poor response to immunotherapy and rectal fibrosis. This study investigated whether node-sparing modified short-course irradiation combined with chemotherapy and PD-1 blockade could be effective in patients with MSS/ pMMR LARC.

methodsThis was a open-label, single-arm, multicentre, prospective phase II trial. 32 LARC patients with MSS/pMMR will receive node-sparing modified short-course radiotherapy (the irradiated planned target volume only included the primary tumour bed but not the tumour-draining lymph nodes, 25 Gy/5f, 5 Gy/f) followed by CAPOX and tislelizumab. CAPOX and tislelizumab will be started two days after the completion of radiotherapy: oxaliplatin 130 mg/m DISCUSSION: In our research, node-sparing modified radiotherapy combined with immunotherapy probably increased the responsiveness of immunotherapy for MSS/pMMR rectal cancer patients, reduced the occurrence of postoperative rectal fibrosis, and improved survival and quality of life. This is the first clinical trial to utilize a node-sparing radiation strategy combined with chemotherapy and PD-1 blockade in the neoadjuvant treatment of rectal cancer, which may result in a breakthrough in the treatment of MSS/pMMR rectal cancer.

trial registrationThis study was registered at www. CLINICALTRIALS: gov . TRIAL REGISTRATION NUMBER: NCT05972655. Date of registration: 31 July 2023.

Indexed as

Antibodies, Monoclonal, HumanizedRectal NeoplasmsAdultAntineoplastic Combined Chemotherapy ProtocolsCapecitabineChemoradiotherapyClinical Trials, Phase II as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicNeoadjuvant TherapyOxaliplatinProspective StudiesAntibodies, Monoclonal, HumanizedCapecitabineOxaliplatintislelizumabChemotherapyLocally advanced rectal cancerMicrosatellite stabilityNodes-sparingPathological complete responseShort-course radiotherapyTislelizumabTotal mesorectal excision

Identifiers

PMID39385104
PMCPMC11463141

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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.