Neoadjuvant Chemoradiotherapy Plus Sintilimab for Intermediate/High Immunoscore Locally Advanced Rectal Cancer: A Single-Center, Open-Label, Single-Arm, Phase 2 Trial
Immunoscore has been reported to be superior to microsatellite instability staging in predicting the disease-specific recurrence and survival for patients with colorectal cancer. However, the relationship between Immunoscore and its impact on patient's response to PD-1 blockade remains to be elucidated. This phase II, prospective, open label study is designed to evaluate the efficacy and safety of combination neoadjuvant chemoradiotherapy (nCRT) with the anti-PD-1 antibody sintilimab for intermediate/high Immunoscore locally advanced rectal cancer.
• Age ≥ 18 years and ≤75 years.
• Willing and able to provide written informed consent for participation in this study.
• Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge).
• Clinical stage of T3/T4 or N positive and M0, before nCRT.
• Non complicated primary tumor (complete obstruction, perforation, bleeding).
• Subjects with an intermediate or high immunoscore (according to Immunoscore®).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy.
• Women of childbearing potential with a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
⁃ Subjects with normal organ and marrow function as defined below:
‣ Leukocytes ≥ 3,000/k/uL; Absolute neutrophil count ≥ 1,500/k/uL; Platelet count ≥ 100,000/k/uL; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); AST (SGOT) ≤ 2.5 x institutional upper limit of normal (ULN); ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN); Serum creatinine ≤ 1.5 x institute upper limit of normal (ULN).