Actively Recruiting
Analysis of the Efficacy of Local Liver Treatment for Multi-organ Colorectal Cancer Metastases: A Prospective, Multicenter, Non-randomized Concurrent Controlled Study
Led by Anhui Provincial Hospital · Updated on 2024-06-10
130
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Anhui Provincial Hospital
Lead Sponsor
F
First Affiliated Hospital of Wannan Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether local radical treatment of liver metastases combined with systemic therapy can improve outcomes in patients with colorectal cancer that has spread to multiple organs. The study aims to determine if this approach can benefit survival compared to systemic therapy alone or combined with other local interventions. It also explores risk factors affecting prognosis, assesses quality of life, and evaluates treatment safety. Participants are assigned based on their preference to one of two groups. One group receives radical local treatment of liver metastases through surgery or ablation combined with systemic therapy, which includes chemotherapy, targeted drugs, or immunotherapy. The other group receives systemic therapy alone or combined with local interventional therapies such as transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC). Participants will be followed every three months for up to two years. During this time, researchers will monitor overall survival, progression-free survival focused on liver metastases, and any adverse events. Quality of life will be assessed using questionnaires. Regular evaluations will include clinical assessments and laboratory tests to ensure safety and track outcomes throughout the study period.
CONDITIONS
Brief Title
Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18-80 years of age
- Volunteered to join the study and signed informed consent, with good compliance and follow-up
- Primary colorectal tumors can be radically resected or confirmed by histopathology
- Diagnosed with liver metastasis and extrahepatic metastasis by CT or MRI; extrahepatic metastases are stable and controllable
- Receiving first- or second-line systemic therapy only
- Radical local treatment can be performed after MDT evaluation, meeting criteria for hepatectomy or ablation
- ECOG performance status of 0-1
- Life expectancy of at least 3 months
- Child-Pugh score 7 or less
- Laboratory tests show no significant abnormalities including ANC ≥ 1.5 x10^9/l, PLT ≥ 100 x10^9/l, Hemoglobin ≥ 9g/dl, TBIL < 1.5 times ULN, ALT and AST < 5 times ULN, Serum creatinine ≤ 1.5 times ULN or Creatinine clearance > 50 ml/min, Albumin > 30 g/l
You will not qualify if you...
- Only liver metastasis confirmed by CT or MRI
- History of hepatic encephalopathy or liver transplantation
- Brain metastases
- Pregnant or breastfeeding women
- History of other malignant tumors (except thyroid cancer and carcinoma in situ) unless disease-free for at least 5 years
- Acute cardiovascular or cerebrovascular diseases within 1 month or uncontrolled symptoms
- NYHA class 3-4 or left ventricular ejection fraction below 50%
- Uncontrolled hypertension or hypertensive crisis history
- Uncontrolled infection above grade 2
- Respiratory insufficiency with low oxygen or high carbon dioxide levels
- Large or malignant ascites
- Coagulation dysfunction with bleeding tendency
- Recent major surgery, severe trauma, fractures, or ulcers within 4 weeks
- History of mental drug abuse or mental disorders
- Any serious concomitant diseases or conditions judged unsafe by the investigator
- Patients deemed unsuitable for inclusion by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive either radical local treatment of liver metastases combined with systemic therapy or systemic therapy alone or combined with local interventional therapy.
Visits according to treatment schedule and assessments
Duration - Up to 2 years
Participants are followed up every 3 months to assess survival, progression, quality of life, and safety.
Quarterly visits for up to 2 years
Trial Site Locations
Total: 6 locations
1
The First People's Hospital of Chu Zhou
Chuzhou, Anhui, China, 233100
Actively Recruiting
2
Fuyang Cancer Hospital
Fuyang, Anhui, China, 236000
Actively Recruiting
3
Anhui province hospital
Hefei, Anhui, China, 230000
Actively Recruiting
4
Ma'anshan People's Hospital
Ma’anshan, Anhui, China, 243000
Actively Recruiting
5
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241000
Actively Recruiting
6
The Second People's Hospital of Wuhu
Wuhu, Anhui, China, 241000
Actively Recruiting
Research Team
J
Ji-Zhou Wang, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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