The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer
Recruiting
Phase 2
Interventional Study
Early Low Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 34 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
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…
Trial Locations
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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 r…
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