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Trial Title:
Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA
NCT ID:
NCT05797077
Condition:
Colorectal Cancer
Liver Metastases
Circulating Tumor Cell
Cancer, Therapy-Related
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Cells, Circulating
Capecitabine
Conditions: Keywords:
Colorectal Cancer
Liver Metastases
ctDNA
maintenance therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Colorectal resection surgery.
Description:
Colorectal cancer radical resection combined with liver metastasis resection or ablation.
Arm group label:
Adjuvant chemotherapy combined with maintenance therapy
Arm group label:
Single adjuvant chemotherapy
Intervention type:
Drug
Intervention name:
FOLFOX chemotherapy regimen
Description:
Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or
single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.
Arm group label:
Adjuvant chemotherapy combined with maintenance therapy
Arm group label:
Single adjuvant chemotherapy
Other name:
CapeOx chemotherapy regimen
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Maintenance therapy is recommended to be continued with low-toxicity drugs such as
5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be
discontinued once ctDNA testing is negative.
Arm group label:
Adjuvant chemotherapy combined with maintenance therapy
Other name:
5-FU/LV
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliate Hospital of Sun Yat-Sen University
Address:
City:
GuangZhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanxin Luo, PhD,MD
Phone:
86-13826190263
Email:
luoyx25@mail.sysu.edu.cn
Contact backup:
Last name:
Yaoyi Huang, BS
Phone:
86-15986423743
Email:
huangyy355@mail2.sysu.edu.cn
Start date:
February 20, 2023
Completion date:
February 20, 2031
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05797077
