An interventional study of Toripalimab and short-term radiotherapy in Locally Advanced, High-Risk and Rectal Cancer, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
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. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 53 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr
60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);
Exclusion Criteria:
A total of 53 patients receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy.
Drug: Toripalimab · Radiation: short-term radiotherapy · Drug: Oxaliplatin · Drug: Capecitabine
Toripalimab 240mg,d1,q3w
25Gy/5Fx
Also known as: shor-course radiotherapy
135mg/m2 d1 q3w
1200mg/m2 d1-14 q3w
pCR rate
Pathologic complete response rate
Time frame: The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
3-year ORR
3-year objective response rate
Time frame: Assessed up to 3 years
3-year DCR
3-year disease control rate
Time frame: Assessed up to 3 years
3-year OS
3-year overall survival rate
Time frame: Assessed up to 3 years
AE
adverse event
Time frame: Assessed up to 3 years
SAE
Serious Adverse Event
Time frame: Assessed up to 3 years
Plan to share: No
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Nanfang Hospital, Southern Medical University