drugset / Trial / NCT06443671

Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer

NCT06443671

Phase 2/3 Not yet recruiting 132 enrolled Peking University Cancer Hospital & Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. The main questions it aims to answer are: * Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMR/MSS locally advanced rectal cancer patients? * What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX? Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients. Participants will: * Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles * Receive radical operations and three years follow-up * Keep a diary of their postoperative pathology results and survival

Timeline

Start
2024-06-01
Primary completion
2026-06-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 825 mg/m2 Oral
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Subject Fruquintinib Small molecule 3 mg Oral
Comparator Oxaliplatin Small molecule 100 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications