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Recruiting NCT06455124

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Phase II Interventional Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation, PD-1 antibody, Capecitabine, Oxaliplatin.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

Detailed description

A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included.

Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.

They will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.

Interventions

  • Radiation Radiation
    Shor-course radiotherapy: 25Gy/5Fx
  • Drug PD-1 antibody
    PD-1 antibody (Toripalimab): 240mg d1 q3w
  • Drug Capecitabine
    Capecitabine: 1000mg/m2 d1-14 q3w
  • Drug Oxaliplatin
    Oxaliplatin: 130mg/m2 d1 q3w

Primary outcome measures

  • 3y LRFS [Time frame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.]
Secondary outcome measures (3)
  • 3y DFS [Time frame: From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.]
  • 3y OS [Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.]
  • Grade 3-4 adverse effects rate [Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.]

Eligibility criteria

Inclusion criteria

  • age 18-75 years old, female and male
  • pathological confirmed adenocarcinoma
  • the distance from anal verge ≤ 7 cm
  • pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (<1mm) at time of local excision, depth of invasion >1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
  • refuse radical surgery
  • without pelvic or distance metastases
  • KPS >=70
  • with good compliance
  • microsatellite repair status is MSS/pMMR
  • without previous anti-cancer therapy or immunotherapy
  • signed the inform consent

Exclusion criteria

  • pregnancy or breast-feeding women
  • pathological confirmed signet ring cell carcinoma
  • 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: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
  • DPD deficiency
  • allergic to any component of the therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06455124 · FDRT-2024-31-3584

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗