NCT05815082 ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
| NCT ID | NCT05815082 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 490 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2031-02-20 |
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 490 participants in total. It began in 2023-02-20 with a primary completion date of 2031-02-20.
⚠ 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 colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.
Eligibility Criteria
Inclusion Criteria: 1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy; 2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy that achieved similar R0 resection effects); 3. Patients with negative ctDNA after surgery; 4. ASA grade \<IV and/or ECOG performance status score ≤ 2; 5. Have sufficient understanding of the study and voluntarily sign an informed consent form. Exclusion Criteria: 1. Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.; 2. Patients with a history of other malignancies; 3. Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy; 4. Patients who are allergic to any component in the study; 5. Patients who have received other tumor-related investigational drug therapy; 6. Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases; 7. 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 that require comprehensive treatment (including mental disorders), and serious abnormal laboratory tests; 8. Patients with a history of severe mental illness; 9. Pregnant or lactating women; 10. Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.
Frequently Asked Questions
Who can join the NCT05815082 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 NCT05815082 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 490 participants.
Is NCT05815082 currently recruiting?
Yes, NCT05815082 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sixth Affiliated Hospital, Sun Yat-sen University to inquire about joining.
Where is the NCT05815082 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05815082 clinical trial?
NCT05815082 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 490 participants.
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