Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
NCT ID: NCT06449937
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
130 participants
INTERVENTIONAL
2024-07-31
2028-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cross-sectional Study of Anorectal Function and Quality of Life in Patients With Middle and Low Rectal Cancer
NCT04697303
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
NCT06609434
Localized Treatment Versus Palliative Chemotherapy in CRC Patients With 10 or More CRLM
NCT06208371
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection
NCT05720559
3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases
NCT04755907
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I (Radical local treatment combined with systematic treatment)
Patients undergo radical local treatment of liver metastases (hepatectomy, ablation) combined with systematic treatment.
Radical local Surgery
Radical local resection of liver metastases ( hepatectomy, ablation )
Systemic therapy
Chemotherapy, targeted drug therapy, immunotherapy treatment.
Group II (systematic treatment only or combined with local interventional therapy)
Patients undergo systemic therapy only or combined with local interventional therapy (TACE, HAIC).
Systemic therapy
Chemotherapy, targeted drug therapy, immunotherapy treatment.
Interventional therapy
Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radical local Surgery
Radical local resection of liver metastases ( hepatectomy, ablation )
Systemic therapy
Chemotherapy, targeted drug therapy, immunotherapy treatment.
Interventional therapy
Transcatheter arterial chemoembolization (TACE) Hepatic arterial infusion chemotherapy (HAIC)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
* Patients receive only first- or second-line systemic therapy.
* Radical local treatment can be performed after MDT evaluation, and the indications at least meet the following one:
* Hepatectomy: liver metastases can be completely (R0) removed and required to retain sufficient functional liver tissue;
* Ablation therapy: The maximum diameter of liver metastases\<3 cm, and the maximum number of ablation ≤ 5.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Life expectancy of at least 3 months.
* Child-Pugh score ≤ 7.
* Laboratory routine examination (blood routine, liver and kidney function, coagulation function, etc.) no significant abnormalities:
* Absolute neutrophil count (ANC) ≥ 1.5×10\^9/l;
* Platelet count (PLT) ≥ 100\*10\^9/l;
* Hemoglobin ≥ 9g/dl;
* TBIL\<1.5 times the upper limit of normal (ULN);
* ALT and AST\< 5\*ULN;
* Serum creatinine ≤ 1.5 \* ULN or Creatinine clearance\> 50 ml/min;
* Albumin \> 30 g/l.
Exclusion Criteria
* History of hepatic encephalopathy or liver transplantation.
* Evidence of brain metastases.
* Pregnant or breast-feeding women.
* History of other malignant tumors (except thyroid cancer and carcinoma in situ) can be included in the study if the individual has remained disease-free for at least 5 years.
* Patients with acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled.
* NYHA class 3-4 or left ventricular ejection fraction (LVEF) \< 50 % by echocardiography.
* Uncontrollable hypertension, blood pressure \> 160 / 95 mmHg after treatment, history of hypertensive crisis or hypertensive encephalopathy.
* Uncontrollable infection \> grade 2 (NCI-CTC version 5.0).
* Patients with respiratory insufficiency : PaO2 \< 60 mmHg at rest , with or without PaCO2 \> 50 mmHg.
* Patients with a large amount of ascites (ultrasound examination showed an echoless area around the liver and spleen, pelvic cavity, and intestinal loops, and the mesentery and intestinal canal were seen floating in the echoless area ) or malignant ascites (cancer cells were found in ascites or ascites CEA was higher than peripheral blood).
* Coagulation dysfunction ( INR \> 1.5 or APTT \> 1.5\*ULN ), with bleeding tendency.
* Long-term unhealed wounds or fractures, major surgery or severe traumatic injury, fracture or ulcer occurred within 4 weeks.
* Patients with a history of mental drug abuse and who could not quit or had mental disorders.
* According to the investigator's judgment, patients with concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
* According to the investigator's judgment, patients who are not suitable for inclusion.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Affiliated Hospital of Wannan Medical College
OTHER
Anhui Provincial Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ji-Zhou Wang, MD PhD
Role: STUDY_DIRECTOR
Anhui province hospital
Xiao-Ming Wang, MD PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Wannan Medical College
Yu-Zhi Hu, MD
Role: PRINCIPAL_INVESTIGATOR
The Second People&amp;#39;s Hospital of Wuhu
Yi-Ming Cao, MD
Role: PRINCIPAL_INVESTIGATOR
Ma&amp;#39;anshan People&amp;#39;s Hospital
Qing-Song Yang, MD
Role: PRINCIPAL_INVESTIGATOR
The First People&amp;#39;s Hospital of Chu Zhou
Si-Hua Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Fuyang Cancer Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First People's Hospital of Chu Zhou
Chuzhou, Anhui, China
Fuyang Cancer Hospital
Fuyang, Anhui, China
Anhui province hospital
Hefei, Anhui, China
Ma'anshan People's Hospital
Ma’anshan, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
The Second People's Hospital of Wuhu
Wuhu, Anhui, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024KY109
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.