NCT04989855

Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib plus Tislelizumab	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

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-08-01
• Completion: 2024-02-01
• First posted: 2021-08-04
• Last updated: 2021-08-04

Locations

1 site across 1 country: China