NCT05797077 Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
| NCT ID | NCT05797077 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2029-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 346 participants in total. It began in 2023-02-20 with a primary completion date of 2029-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.
Eligibility Criteria
Inclusion Criteria: 1. Both males and females, aged 18-75 years; 2. Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect); 3. Postoperative ctDNA-positive patients; 4. ASA grade \< IV and/or ECOG performance status score ≤ 2; 5. Participants must have a full understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: 1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc. 2. Patients with a history of other malignant tumors. 3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy. 4. Patients who are allergic to any component of the study. 5. Patients who have received other tumor-related investigational drug treatments. 6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases. 7. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities. 8. Patients with a history of severe mental illness. 9. Pregnant or lactating women. 10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.
Frequently Asked Questions
Who can join the NCT05797077 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05797077 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 346 participants.
Is NCT05797077 currently recruiting?
Yes, NCT05797077 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sixth Affiliated Hospital, Sun Yat-sen University to inquire about joining.
Where is the NCT05797077 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05797077 clinical trial?
NCT05797077 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 346 participants.
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