Actively Recruiting
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
Led by Nanfang Hospital, Southern Medical University · Updated on 2023-07-05
53
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
S
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
CONDITIONS
Official Title
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, female and male
- Pathologically confirmed MSS or pMMR rectal adenocarcinoma
- Clinical stage T3-4 (AJCC 8th) with at least one high-risk factor (CRM+ or EMVI+ or lateral lymph nodes+)
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment
- Adequate organ function defined at baseline with ANC ≥1.5×10⁹/L, PLt ≥100×10⁹/L, Hb ≥90 g/L, WBC between 4×10⁹/L and 15×10⁹/L
- Liver and kidney function within 1.5 times the upper limit of normal or creatinine clearance ≥60 ml/min
- INR or PT ≤1.5 times the upper limit of normal if not on anticoagulant therapy
- Women of childbearing age must use reliable contraception or have a negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- Pathologically confirmed rectal squamous cell carcinoma
- History of other uncured malignancies within 5 years
- Allergy to any component of chemotherapy or immunotherapy
- History of any active, known, or suspected autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- Congenital or acquired immunodeficiency such as HIV infection
- Active hepatitis B or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yi Ding, MD
CONTACT
Y
Yaowei Zhang, MD
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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