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Trial Title:
ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
NCT ID:
NCT05815082
Condition:
Colorectal Cancer
Liver Metastases
Circulating Tumor Cell
Chemotherapy Effect
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Cells, Circulating
Conditions: Keywords:
Colorectal Cancer
Liver Metastases
Circulating Tumor DNA
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 cancer resection combined with liver metastasis resection.
Description:
The preferred surgical approach is resection of the corresponding colon segment with
regional lymph node dissection. If conditions permit, synchronous resection of the
primary lesion and liver metastases of colorectal cancer can be performed to achieve
curative resection.
Arm group label:
Adjuvant chemotherapy group
Arm group label:
Watching and waiting group
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 group
Other name:
CapeOx chemotherapy regimen
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.
Criteria for 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
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, 2033
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/NCT05815082
