RecruitingPhase 2NCT06455124

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

Sponsor

Fudan University

Enrollment

60 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Rectal Cancer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

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 Criteria8

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