Actively Recruiting
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Led by Fudan University · Updated on 2024-06-13
60
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, both female and male
- Pathologically confirmed adenocarcinoma
- Tumor located 7 cm or less from the anal verge
- pT1 stage after local excision with at least one high-risk feature such as margin positivity or very close margin (<1 mm), depth of invasion >1 mm or SM3 invasion, high-grade or poorly differentiated tumor, lymphovascular invasion, perineural invasion, tumor budding, or pT2 tumor
- Refusal of radical surgery
- No pelvic or distant metastases
- Karnofsky Performance Status (KPS) of 70 or higher
- Good treatment compliance
- Microsatellite stable (MSS) or proficient mismatch repair (pMMR) status
- No previous anti-cancer therapy or immunotherapy
- Signed informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Pathologically confirmed signet ring cell carcinoma
- History of other malignancies within the past 5 years
- Serious medical illnesses such as severe mental disorders, cardiac disease, or uncontrolled infection
- Immunodeficiency or long-term use of immunosuppressive agents
- Blood and biochemical test results outside specified ranges: neutrophils <1.5 x 10^9/L, hemoglobin <90 g/L, platelets <100 x 10^9/L, ALT/AST >2.5 times upper limit of normal, creatinine >1 times upper limit of normal
- DPD deficiency
- Allergy to any component of the therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Z
Zhen Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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