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NOT YET RECRUITING
NCT06443671
PHASE2/PHASE3

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

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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

Official title: Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Open-label, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2024-06-01

Completion Date

2028-06-01

Last Updated

2024-06-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

CapeOX

Receiving CapeOX treatment for up to four cycles before surgery: Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.

DRUG

Fruquintinib and Tislelizumab combined with mCapeOX

Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery: Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, Haidian District, China