Health TrialsbyHealthPanel

Local Liver Treatment for Multi-organ Colorectal Cancer Metastases

ConditionsMetastatic Colorectal CarcinomaMulti-organ Metastatic Colorectal CancerMetastatic Malignant Neoplasm in the Liver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnhui Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18-80 years of age.

Patients volunteered to join the study and signed informed consent, with good compliance and follow-up.

Primary colorectal tumors can be radically resected or resected and histopathologically diagnosed as colorectal cancer.

Patients with synchronous or metachronous diagnosis of liver metastasis and extrahepatic metastasis by computed tomography (CT) or magnetic resonance imaging (MRI).Extrahepatic metastases are stable and controllable as determined by Multi-disciplinary Treatment (MDT).

Disqualifiers

Patients with only liver metastasis confirmed by CT or MRI.

History of hepatic encephalopathy or liver transplantation.

Evidence of brain metastases.

Pregnant or breast-feeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radical local Surgery

    Procedure/Surgery

    Radical local resection of liver metastases ( hepatectomy, ablation )

  • Systemic therapy

    Drug

    Chemotherapy, targeted drug therapy, immunotherapy treatment.

  • Interventional therapy

    Other intervention

    Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Group I (Radical local treatment combined with systematic treatment)Experimental treatment 2 interventions
Group B: Group II (systematic treatment only or combined with local interventional therapy)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Collaborator

Source ClinicalTrials.gov
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