The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Locally Advanced Rectal Cancer (TORCH)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    130
  • sponsor
    Fudan University
Updated on 4 October 2022

Summary

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in locally advanced rectal cancer (LARC). Patients are randomly assigned into two prospective cohorts: consolidation cohort and induction cohort. Consolidation cohort: A total of 65 patients will receive 55Gy short-course radiotherapy, followed by 6 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the total mesorectal excision (TME). Induction cohort: A total of 65 patients will firstly receive 2 cycles of CAPOX chemotherapy and PD-1 antibody, then receive 55Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery. The rate of pathological complete response (pCR), long-term prognosis and adverse effects will be analyzed.

Details
Condition Locally Advanced Rectal Cancer
Treatment Capecitabine, Oxaliplatin, PD-1 antibody, Short-course Radiotherapy
Clinical Study IdentifierNCT04518280
SponsorFudan University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

pathological confirmed adenocarcinoma
clinical stage T3-4 and/or N+
the distance from anal verge less than 12 cm
without distance metastases
age 18-70 years old, female and male
KPS >=70
without previous anti-cancer therapy or immunotherapy
with good compliance
signed the inform consent

Exclusion Criteria

pregnancy or breast-feeding women
history of other malignancies within 5 years
serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc
immunodeficiency disease or long-term using of immunosuppressive agents
baseline blood and biochemical indicators do not meet the following criteria: neutrophils1.510^9/L, Hb90g/L, PLT10010^9/L, ALT/AST 2.5 ULN, Cr 1 ULN
DPD deficiency
allergic to any component of the therapy
Clear my responses

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