Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: short-course radiotherapy plus chemotherapy and immunotherapy A total of 53 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy. |
Drug: Toripalimab
Toripalimab 240mg,d1,q3w
Radiation: short-term radiotherapy
25Gy/5Fx
Other Names:
Drug: Oxaliplatin
135mg/m2 d1 q3w
Drug: Capecitabine
1200mg/m2 d1-14 q3w
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 3-year ORR [Assessed up to 3 years]
3-year objective response rate
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-75 years old, female and male;
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Pathological confirmed MSS or pMMR rectal adenocarcinoma;
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Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;
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No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
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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
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60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);
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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:
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Pathological confirmed rectal squamous cell carcinoma;
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History of other uncured malignancies within 5 years;
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Allergic to any component of chemotherapy or immunotherapy;
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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.
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With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanfang Hospital Southern Medical University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Shanghai Junshi Bioscience Co., Ltd.
Investigators
- Principal Investigator: Dehua Wu, MD, Nanfang Hospital of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2023-062