This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Sintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy
Objective response rate refers to the proportion of patients who achieve complete response (CR) and partial response (PR) among the treated patients within a certain period of time.
Time frame: From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy
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