Combining immunotherapy with short-course radiotherapy for early rectal cancer
A Prospective Phase II Trial of Immunotherapy Combined With Short-course Radiotherapy in Early Low Rectal Cancer
This study is testing if combining a type of immunotherapy with short radiation treatment can help people with early low rectal cancer have better outcomes after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05555888 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining PD-1 antibody immunotherapy with neoadjuvant short-course radiotherapy in patients with early low rectal cancer. A total of 34 participants will undergo a regimen of 5 sessions of 5Gy radiotherapy, followed by 4 cycles of chemotherapy using capecitabine and oxaliplatin, and then proceed to surgical excision. The study aims to analyze the rates of complete response, organ retention, long-term prognosis, and any adverse effects resulting from the treatment combination.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with confirmed adenocarcinoma of clinical stage T1-3bN0 and specific tumor characteristics.
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 approach could improve treatment outcomes and organ preservation for patients with early rectal cancer.
How similar studies have performed: While the combination of immunotherapy and radiotherapy is being explored in various cancers, this specific approach in early rectal cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18-70 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage T1-3bN0, 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, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- 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.