Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Recruiting · NCT05797467 · Interventional (participants receive a specific treatment) · Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
BevacizumabFOLFOX chemotherapy regimens
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Both sexes, aged 18-75 years;
- Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
- ASA grade \< IV and/or ECOG performance status score ≤ 2 points;
- Fully understand and voluntarily sign the informed consent form for this study.
Exclusion criteria
- A history of other malignant tumors;
- Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
- Patients allergic to any component in the study;
- Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
- Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests;
- Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
- Patients with a history of severe mental illness;
- Pregnant or lactating women;
- Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
Where it is running
1 location listed.
- The Sixth Affiliate Hospital of Sun Yat-Sen University - Guangzhou, Guangdong, China