Evidence map›Paper›PMID 35291966›Full record

Trial reportBMC cancer2022

Short-course radiotherapy combined with CAPOX and Toripalimab for the total neoadjuvant therapy of locally advanced rectal cancer: a randomized, prospective, multicentre, double-arm, phase II trial (TORCH).

Yaqi Wang, Lijun Shen, Juefeng Wan, Hui Zhang, Ruiyan Wu, Jingwen Wang, Yan Wang, Ye Xu, Sanjun Cai, Zhen Zhang and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04518280 (A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
4.6field-weighted citation impact, top 4% 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.

NCT04518280 phase2completednot on this map

A Prospective Phase II Trial of Short-course Radiotherapy Based Total Neoadjuvant Therapy Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer (TORCH)

TypeinterventionalSponsorFudan UniversityRan2021 to 2025Enrolled130ConditionsLocally Advanced Rectal CancerArmsPD-1 antibody, Capecitabine, Oxaliplatin, Short-course radiotherapy
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Yaqi WangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Lijun ShenDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Juefeng WanDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Hui ZhangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ruiyan WuDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Jingwen WangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Yan WangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Ye XuDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Sanjun CaiDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Zhen ZhangDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Fan XiaDepartment of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. tcxiafan@hotmail.com.ORCID http://orcid.org/0000-0001-8185-8663
Shanghai Medical College of Fudan University · CN

Funding

Wu Jie Ping Medical Foundation HYHX2021010
6 · The paper itself

Abstract

backgroundFor patients with locally advanced (T3-4/N +) rectal cancer (LARC), the standard treatment is neoadjuvant chemoradiotherapy combined with total mesorectal resection, which greatly decreases local recurrence but does not improve overall survival. For patients who achieve a complete clinical response (cCR) after nCRT, a "Watch & Wait" (W&W) approach can be received to improve quality of life. Currently, total neoadjuvant therapy (TNT) has been demonstrated to increase the complete response rate and achieve early control of distant metastasis. Recent studies have shown promising synergistic effects of the combination of immunotherapy (PD-1/PD-L1 antibodies) and radiotherapy. Thus, for LARC patients, the combination of immunotherapy and TNT is likely to further improve the rate of complete response and prognosis. The disparities between induction therapy and consolidation therapy need to be investigated.

methodsTORCH is a randomized, prospective, multicentre, double-arm, phase II trial of short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy in LARC. 130 LARC patients will be treated with the TNT approach and assigned to the consolidation arm and induction arm. The consolidation arm will receive SCRT, followed by 6 cycles of capecitabine plus oxaliplatin (CAPOX) and Toripalimab. The induction arm will first receive 2 cycles of CAPOX and Toripalimab, then receive SCRT, followed by 4 cycles of CAPOX and Toripalimab. Both groups will receive curative surgery or the W&W strategy. The primary endpoint is the complete response rate (rate of pCR plus cCR). The secondary endpoints include the grade 3-4 acute adverse effects rate, 3-year disease-free survival (DFS) rate, 3-year local recurrence-free survival (LRFS) rate, 3-year OS rate, rate of surgical complications and quality of life (QoL) scores. The "pick the winner" method is used to investigate the better treatment regimen. The trial was opened on 13th April 2021, and the first patient was recruited on 6th May 2021. DISCUSSION: TORCH will investigate whether SCRT combined with chemotherapy and Toripalimab can achieve better complete response rates, good tolerance and prognosis in LARC patients. This is the first clinical trial to compare the efficacy of induced immunotherapy and consolidative immunotherapy based on the TNT strategy.

trial registrationTrial Registration Number and Date of Registration: ClinicalTrials.gov NCT04518280 , August 15, 2020.

Indexed as

Quality of LifeRectal NeoplasmsAntibodies, Monoclonal, HumanizedCapecitabineHumansNeoadjuvant TherapyOxaliplatinProspective StudiesAntibodies, Monoclonal, HumanizedCapecitabineOxaliplatintoripalimabComplete responseImmunotherapyLocally advanced rectal cancerShort-course radiotherapyTotal neoadjuvant therapy

Identifiers

PMID35291966
PMCPMC8922781
OpenAlexW4220790906

What OpenQuestion holds

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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.