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NCT05877573 | Recruiting | Locally Advanced

Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
Sponsor:

Nanfang Hospital, Southern Medical University

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

Locally Advanced

High-Risk

Rectal Cancer

MSS

Intervention/treatment

Toripalimab

short-term radiotherapy

Oxaliplatin

Capecitabine

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 53 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : August 1, 2026
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

Radiation: short-term radiotherapy

Drug: Oxaliplatin

Drug: Capecitabine
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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;
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer

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Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer

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Locations

Recruiting

China, Guangdong

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China, 510000