PMID- 35291966
OWN - NLM
STAT- MEDLINE
DCOM- 20220404
LR  - 20220405
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Mar 15
TI  - 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).
PG  - 274
LID - 10.1186/s12885-022-09348-z [doi]
LID - 274
AB  - BACKGROUND: For 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. METHODS: 
      TORCH 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 REGISTRATION: Trial Registration Number and Date of 
      Registration: ClinicalTrials.gov NCT04518280 , August 15, 2020.
CI  - (c) 2022. The Author(s).
FAU - Wang, Yaqi
AU  - Wang Y
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Shen, Lijun
AU  - Shen L
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Wan, Juefeng
AU  - Wan J
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Zhang, Hui
AU  - Zhang H
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Wu, Ruiyan
AU  - Wu R
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Wang, Jingwen
AU  - Wang J
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Wang, Yan
AU  - Wang Y
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Xu, Ye
AU  - Xu Y
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Cai, Sanjun
AU  - Cai S
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Department of Colorectal Surgery, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
FAU - Zhang, Zhen
AU  - Zhang Z
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China.
FAU - Xia, Fan
AU  - Xia F
AUID- ORCID: 0000-0001-8185-8663
AD  - Department of Radiation Oncology, Fudan University Shanghai Cancer Center, 
      Shanghai, China. tcxiafan@hotmail.com.
AD  - Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 
      China. tcxiafan@hotmail.com.
AD  - Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. 
      tcxiafan@hotmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04518280
GR  - HYHX2021010/Wu Jie Ping Medical Foundation/
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220315
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 04ZR38536J (Oxaliplatin)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - 8JXN261VVA (toripalimab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - Capecitabine
MH  - Humans
MH  - Neoadjuvant Therapy/methods
MH  - Oxaliplatin/therapeutic use
MH  - Prospective Studies
MH  - *Quality of Life
MH  - *Rectal Neoplasms/pathology
PMC - PMC8922781
OTO - NOTNLM
OT  - Complete response
OT  - Immunotherapy
OT  - Locally advanced rectal cancer
OT  - Short-course radiotherapy
OT  - Total neoadjuvant therapy
COIS- The authors declare that they have no competing interests.
EDAT- 2022/03/17 06:00
MHDA- 2022/04/05 06:00
PMCR- 2022/03/15
CRDT- 2022/03/16 05:40
PHST- 2021/12/17 00:00 [received]
PHST- 2022/02/28 00:00 [accepted]
PHST- 2022/03/16 05:40 [entrez]
PHST- 2022/03/17 06:00 [pubmed]
PHST- 2022/04/05 06:00 [medline]
PHST- 2022/03/15 00:00 [pmc-release]
AID - 10.1186/s12885-022-09348-z [pii]
AID - 9348 [pii]
AID - 10.1186/s12885-022-09348-z [doi]
PST - epublish
SO  - BMC Cancer. 2022 Mar 15;22(1):274. doi: 10.1186/s12885-022-09348-z.