NCT05555888 The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
| NCT ID | NCT05555888 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fudan University |
| Condition | Early Low Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2024-03-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2022-12-12 with a primary completion date of 2024-03-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05555888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Early Low Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05555888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05555888 currently recruiting?
Yes, NCT05555888 is actively recruiting participants. Contact the research team at zhen_zhang@fudan.edu.cn for enrollment information.
Where is the NCT05555888 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05555888 clinical trial?
NCT05555888 is sponsored by Fudan University. The trial plans to enroll 34 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.