High-Risk, Locally Advanced, MSS, Rectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGToripalimab
Toripalimab 240mg,d1,q3w
RADIATIONshort-term radiotherapy
25Gy/5Fx
DRUGOxaliplatin
135mg/m2 d1 q3w
DRUGCapecitabine
1200mg/m2 d1-14 q3w
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years old, female and male; * Pathological confirmed MSS or pMMR rectal adenocarcinoma; * Clinical stage T3-4 (AJCC 8th) and at least with 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 as: ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr * 60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy); * Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;
Exclusion criteria
* Pathological confirmed rectal squamous cell carcinoma; * History of other uncured malignancies within 5 years; * Allergic 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, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis. * With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months | Pathologic complete response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year DCR | Assessed up to 3 years | 3-year disease control rate |
| 3-year OS | Assessed up to 3 years | 3-year overall survival rate |
| AE | Assessed up to 3 years | adverse event |
| SAE | Assessed up to 3 years | Serious Adverse Event |
| 3-year ORR | Assessed up to 3 years | 3-year objective response rate |
Countries
China
Contacts
Primary ContactYi Ding, MD
Backup ContactYaowei Zhang, MD
Outcome results
None listed