NCT05815082RecruitingPhase 3
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 490 (estimated)
- First submitted
- 20 Mar 2023
- Start date
- 20 Feb 2023
- Primary completion date
- 20 Feb 2031
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05815082
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 490
- From 20 Feb 2023 to the primary completion date, 20 Feb 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received other tumor-related investigational drug therapy;
- Patients with severe uncontrolled recurrent infections or other serious uncontrolled concurrent diseases;
Other illness
- Patients with a history of other malignancies;
- Patients with severe liver, kidney, heart and lung dysfunction, coagulation dysfunction, or serious underlying diseases who cannot tolerate chemotherapy;
- Patients who are allergic to any component in the study;
- Patients with a history of severe mental illness;
Lab values
- 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;
- Patients with other clinical or laboratory conditions that the investigator deems unsuitable for participation in the trial.
Other
- Patients with distant metastases, including pelvic, ovarian, peritoneal, etc.;
- Pregnant or lactating women;
Who the study is looking for
- Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
- 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);
- Patients with negative ctDNA after surgery;
- ASA grade \<IV and/or ECOG performance status score ≤ 2;
- Have sufficient understanding of the study and voluntarily sign an informed consent form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliate Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.