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

Not Applicable

Recruiting

• Conditions: Locally Advanced; MSS; Rectal Cancer; High-Risk
• Interventions: Drug: Toripalimab; Radiation: short-term radiotherapy; Drug: Oxaliplatin; Drug: Capecitabine

• Registration Number: NCT05877573
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-26
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Last Update Submitted: 2023-07-02
• Last Update Posted: 2023-07-05
• Primary Completion: 2025-01-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
short-course radiotherapy plus chemotherapy and immunotherapy	short-term radiotherapy	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.
short-course radiotherapy plus chemotherapy and immunotherapy	Toripalimab	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.
short-course radiotherapy plus chemotherapy and immunotherapy	Capecitabine	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.
short-course radiotherapy plus chemotherapy and immunotherapy	Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Nanfang Hospital Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China