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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
2 cycles of Fruquintinib(F) 5mg QD d1-d14 + Tislelizumab(T) 200mg IV d1, Q3W as preoperative therapy, and F +T after TME as postoperative therapy for 6 months
651 Dongfeng Road East
Guangzhou, Guangdong, China
ORR
Objective Response Rate
Time frame: up to 3 years
3-year RFS
3-year relapse-free survival
Time frame: up to 3 years
3-year OS
3-year overall survival
Time frame: up to 3 years
Safety and Tolerability
treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.