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Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
Sponsor: Tang-Du Hospital
Summary
(1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.
Official title: One Arm Exploratory Trial of Efficacy and Safety of TNT Plus Mode With Neoadjuvant Radiotherapy in the Treatment of Locally Advanced Medium-low Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
213
Start Date
2023-11-10
Completion Date
2027-11-10
Last Updated
2023-09-13
Healthy Volunteers
No
Conditions
Interventions
CapeOX + cetuximab
CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
CapeOX + bevacizumab
CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
radiotherapy
radiotherapy