The purpose of this study was to investigate the effect of only local radical treatment of liver metastases combined with systematic treatment in the treatment of patients with multiple organ metastases of colorectal cancer, whether it can benefit the prognosis and explore the risk factors related to the prognosis.
Primary objective: 1.To determine the survival benefit of local radical resection of liver metastases in patients with resectable liver and controllable extrahepatic metastases from colorectal cancer. Secondary objectives: 1. To explore the prognosis-related risk factors in patients with colorectal cancer liver metastases combined with extrahepatic metastases 2. To assess patients' quality-of-life in each treatment group with questionnaires. 3. To evaluate the safety of the treatment in each treatment group. Grouping Method: Patients are assigned to 1 of 2 groups according to their willingness. GROUP I: Patients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systemic therapy. GROUP II: Patients receive Systemic therapy only or combined local interventions (TACE, HAIC) Patients are followed up every 3 months up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Radical local resection of liver metastases ( hepatectomy, ablation )
Chemotherapy, targeted drug therapy, immunotherapy treatment.
Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)
The First People's Hospital of Chu Zhou
Chuzhou, Anhui, China
RECRUITINGFuyang Cancer Hospital
Fuyang, Anhui, China
RECRUITINGAnhui province hospital
Hefei, Anhui, China
Overall survival
Differences in overall survival between the two arms were assessed using the log-rank test; Cox proportional hazards regression models were used to determine the factors and hazard ratios associated with overall survival.
Time frame: From date of study inclusion until the date of death or or the date of last follow-up, assessed up to 2 years
Liver-specific progression free survival rates
The Kaplan-Meier method will be used to estimate time to intrahepatic recurrence or progression or death from any cause in patients.
Time frame: Date of study inclusion to until local recurrence or progression in the liver or death from any cause, assessed up to 2 years
Incidence of adverse events
Record the frequency and percentage of adverse events, their grade, and their relationship to radical local treatment.
Time frame: Assessed up to 2 years
Quality of life scores-EORTC QLQ-C30 (version 3) questionnaire
Summarized using descriptive statistics, including mean, standard deviation, median and range.
Time frame: Assessed up to 2 years
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Ma'anshan People's Hospital
Ma’anshan, Anhui, China
RECRUITINGThe First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
RECRUITINGThe Second People's Hospital of Wuhu
Wuhu, Anhui, China
RECRUITING