About this trial
Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.
Study Design:A single-arm, multicenter clinical study.
Study Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed rectal adenocarcinoma;
Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;
Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter > 8 mm); patients with potentially resectable disease;
Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;
Disqualifiers
Recurrent rectal cancer;
Synchronous colorectal cancer;
Pregnant or lactating patients;
History of other malignant tumors;
Trial design
Single group
Treatments tested in this trial
PD-1
Drugpatients will receive short-course chemotherapy and concurrent PD-1
Treatment groups
Trial outcomes
Primary outcomes
pathological complete response rate
the incidence of no tumor residual after the treatment
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: