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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877573
• Other study ID #: NFEC-2023-062
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: July 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Yi Ding, MD
• Phone: 86-20-13729852980
• Email: dingyi197980[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: August 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• High-Risk
• Locally Advanced
• MSS
• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Toripalimab
Toripalimab 240mg,d1,q3w

Radiation:
• short-term radiotherapy
25Gy/5Fx

Drug:
• Oxaliplatin
135mg/m2 d1 q3w
• Capecitabine
1200mg/m2 d1-14 q3w

Locations

Country	Name	City	State
China	Nanfang Hospital Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University	Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR rate	Pathologic complete response rate	The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Secondary	3-year ORR	3-year objective response rate	Assessed up to 3 years
Secondary	3-year DCR	3-year disease control rate	Assessed up to 3 years
Secondary	3-year OS	3-year overall survival rate	Assessed up to 3 years
Secondary	AE	adverse event	Assessed up to 3 years
Secondary	SAE	Serious Adverse Event	Assessed up to 3 years