Combining targeted therapy with chemotherapy for advanced colorectal cancer
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
This study is testing if adding a targeted therapy to standard chemotherapy can help people with advanced colorectal cancer live longer without their cancer coming back after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05797467 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of adjuvant chemotherapy alone versus adjuvant chemotherapy combined with targeted therapy in patients with resectable stage T3-4N2 colorectal cancer. The primary focus is to determine if the addition of targeted therapy improves disease-free survival rates. Participants will receive FOLFOX chemotherapy regimens, with some also receiving Bevacizumab as part of the targeted therapy. The study will involve patients aged 18-75 who have undergone surgery for their cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma who have undergone surgery.
Not a fit: Patients with severe underlying health conditions or those with a history of other malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved disease-free survival for patients with advanced colorectal cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and targeted therapy in colorectal cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.