Actively Recruiting
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
Led by Fudan University · Updated on 2024-06-17
134
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
CONDITIONS
Official Title
Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Pathologically confirmed adenocarcinoma
- Clinical stage T1-3bN0-1 with tumor size less than 4 cm
- Tumor located within 5 cm from the anal verge
- No distant metastases present
- Karnofsky Performance Score (KPS) of 70 or higher
- Good compliance with study procedures
- Microsatellite stability status MSS/pMMR
- No previous anti-cancer therapy or immunotherapy
- Signed informed consent form
You will not qualify if you...
- Pregnancy or breastfeeding
- Confirmed signet ring cell carcinoma
- Clinical stage T1N0 tumor suitable for local resection
- History of other malignancies within past 5 years
- Serious medical illnesses such as severe mental disorders, cardiac disease, or uncontrolled infections
- Immunodeficiency or long-term use of immunosuppressive drugs
- Blood and biochemistry values outside required 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, creatinine >1 times upper limit
- DPD enzyme deficiency
- Allergy to any study treatment components
AI-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, M.D, PH.D
CONTACT
Y
Yajie Chen, PH.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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