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RECRUITING
NCT05797467
PHASE3

Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial\] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.

Official title: Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2023-04-01

Completion Date

2033-04-01

Last Updated

2023-05-24

Healthy Volunteers

No

Interventions

DRUG

FOLFOX chemotherapy regimens

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

DRUG

Bevacizumab

Targeted therapy regimens are recommended based on gene testing results. For colorectal cancer patients with KRAS/NRAS/BRAF gene mutations, it is recommended to use Bevacizumab in combination with chemotherapy. For right-sided colon cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Bevacizumab. For left-sided colon and rectal cancer patients with wild-type KRAS/NRAS/BRAF genes, it is recommended to use Cetuximab.When using targeted therapy in combination with chemotherapy, the treatment course should be synchronized with chemotherapy (Bev 5mg/kg iv d1 or Cet 500mg/m2 iv d1).

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China