Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Recruiting now · Phase 2
Conditions studied: Rectal Cancer
In brief
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.
Key facts
- Study ID
- NCT06455124
- Run by
- Fudan University
- People needed
- 60
- Starts
- 2024-05-08
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2024-06-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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