Comparing short-course and long-course treatments for early low-lying rectal cancer
A Prospective, Randomized, Phase II Trial of Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
This study is testing whether a shorter treatment with radiation and chemotherapy can work better for people with early low-lying rectal cancer compared to a longer treatment plan.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06462053 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of short-course radiotherapy combined with CAPOX chemotherapy and a PD-1 antibody against long-course chemoradiotherapy combined with CAPOX for patients with early low-lying rectal cancer. A total of 134 patients will be randomly assigned to either treatment group, with the primary goal of assessing the complete response rate. Secondary outcomes include the rate of severe adverse effects, anal preservation, and disease-free survival over three years. The trial aims to determine the best approach to improve treatment outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with early-stage adenocarcinoma of the rectum, specifically T1-3bN0-1 tumors located less than 5 cm from the anal verge.
Not a fit: Patients with signet ring cell carcinoma, those who can undergo local resection, or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to more effective treatment options and improved outcomes for patients with early low-lying rectal cancer.
How similar studies have performed: Other studies have shown promise in using similar combinations of therapies for rectal cancer, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18-75 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm 4. the distance from anal verge less than 5 cm 5. without distance metastases 6. KPS \>=70 7. with good compliance 8. microsatellite repair status is MSS/pMMR 9. without previous anti-cancer therapy or immunotherapy 10. signed the inform consent Exclusion Criteria: 1. pregnancy or breast-feeding women 2. pathological confirmed signet ring cell carcinoma 3. clinical stage T1N0 and can be resected locally 4. history of other malignancies within 5 years 5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 6. immunodeficiency disease or long-term using of immunosuppressive agents 7. 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 8. DPD deficiency 9. allergic to any component of the therapy
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, M.D, PH.D — Fudan University
- Study coordinator: Zhen Zhang, M.D, PH.D
- Email: zhen_zhang@fudan.edu.cn
- Phone: 18801735029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.