Combining short-course radiotherapy with chemotherapy and immunotherapy for high-risk early rectal cancer

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

This study is testing a new treatment plan that combines short radiation therapy with chemotherapy and immunotherapy to see if it helps people with high-risk early rectal cancer who can't have major surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06455124 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the effectiveness and safety of a treatment regimen for patients with high-risk early rectal cancer who have undergone local excision but declined radical surgery. The study will enroll 60 patients with specific high-risk features and will administer a short-course radiotherapy followed by a combination of capecitabine, oxaliplatin, and a PD-1 inhibitor. The primary outcome measure is the three-year local recurrence-free survival (LRFS). This approach aims to provide an alternative treatment pathway for patients who are not candidates for more invasive surgical options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with high-risk pT1 or pT2 rectal adenocarcinoma after local excision who refuse radical surgery.

Not a fit: Patients with signet ring cell carcinoma, those with a history of other malignancies within the last five years, or those with serious medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a less invasive option for managing high-risk early rectal cancer while maintaining effective cancer control.

How similar studies have performed: Other studies have shown promising results with similar approaches combining radiotherapy and immunotherapy, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. age 18-75 years old, female and male
2. pathological confirmed adenocarcinoma
3. the distance from anal verge ≤ 7 cm
4. pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor.
5. refuse radical surgery
6. without pelvic or distance metastases
7. KPS \>=70
8. with good compliance
9. microsatellite repair status is MSS/pMMR
10. without previous anti-cancer therapy or immunotherapy
11. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. pathological confirmed signet ring cell carcinoma
3. history of other malignancies within 5 years
4. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
5. immunodeficiency disease or long-term using of immunosuppressive agents
6. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
7. DPD deficiency
8. allergic to any component of the therapy

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhen Zhang

Conditions Rectal Cancer; early rectal cancer; high risk; local excision; radiation; PD-1 inhibitor; chemotherapy