Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer
Recruiting
N/A
Interventional Study
Locally Advanced
High-Risk
Rectal Cancer
MSS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 53 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Other
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About This Trial
This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. The…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-75 years old, female and male;
* Pathological confirmed MSS or pMMR rectal adenocarcinoma;
* Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor(CRM+ or EMVI+ or lateral lymph nodes+);
* No previous chemotherapy, radiotherapy, immunotherapy or other an…
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