Combining toripalimab with chemoradiotherapy for high-risk rectal cancer

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

This study is testing if adding a new drug called toripalimab to standard chemotherapy and radiation can help people with high-risk rectal cancer do better before their surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, toripalimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05877573 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of toripalimab, a PD-1 antibody, in combination with neoadjuvant short-course radiotherapy and chemotherapy for patients with locally advanced, high-risk rectal cancer. A total of 53 patients will receive 5 sessions of 5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and toripalimab, before undergoing total mesorectal excision (TME) surgery and additional chemotherapy. The primary goal is to assess the rate of pathological complete response (pCR), along with long-term prognosis and adverse effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with locally advanced, high-risk MSS rectal adenocarcinoma and no prior cancer treatments.

Not a fit: Patients with rectal squamous cell carcinoma or those with a history of other uncured malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with high-risk rectal cancer.

How similar studies have performed: While this specific combination is novel, similar approaches using immunotherapy and chemoradiotherapy have shown promise in other studies.

Eligibility 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;

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Dehua Wu, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Yi Ding, MD

Conditions Locally Advanced; High-Risk; Rectal Cancer; MSS