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

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

Recruiting
18-75 years
All
Phase 3

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Both sexes, aged 18-75 years;
  2. Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery;
  3. ASA grade < IV and/or ECOG performance status score ≤ 2 points;
  4. Fully understand and voluntarily sign the informed consent form for this study.

Exclusion Criteria:

  1. A history of other malignant tumors;
  2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy;
  3. Patients allergic to any component in the study;
  4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases;
  5. 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;
  6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.;
  7. Patients with a history of severe mental illness;
  8. Pregnant or lactating women;
  9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.

Study details
    Colorectal Cancer
    Chemotherapy Effect

NCT05797467

Sixth Affiliated Hospital, Sun Yat-sen University

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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