Locally Advanced Rectal Cancer Clinical Trial
Official title:
Fruquintinib Combined With PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score: an Open-label, Multi-center, Phase II Clinical Trial
This is a prospective, one arm phase II study aimed to observe the efficacy and safety of tislelizumab combined with fruquintinib in treatment of patients with pMMR / MSS locally advanced rectal cancer with high immune score.
48 patients of pMMR / MSS locally advanced rectal cancer with high immune score will be administered with tislelizumab (200mg IV d1, Q3W ) combined with fruquintinib (5mg QD d1-d14, Q3W) with a total of 2 cycles as neoadjuvant therapy. After TME, tislelizumab and fruquintinib will be given again for up to 6 months as adjuvant therapy. If the patient after neoadjuvant therapy is evaluated as SD/PD, the neoadjuvant therapy will be converted to neoadjuvant chemo-radiotherapy/chemotherapy or palliative therapy, and then the patient will be treated according to the norms of adjuvant therapy for rectal cancer if TME is performed. If the patient choose Watch & Wait when evaluated as CR, tislelizumab plus fruquintinib for at least one year is requested. ;
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