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New treatment option for Metastatic Colorectal Carcinoma
Official title Local Liver Treatment for Multi-organ Colorectal Cancer Metastases
ClinicalTrials.gov ID: NCT06449937
What this study is testing
What is Systemic therapy?
Systemic therapy is an investigational medicine, being studied as a potential treatment for metastatic colorectal carcinoma.
Also referred to as Chemotherapy, Cancer, General, Targeted therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Patients receive only first- or second-line systemic therapy.
You likely can't join if
- 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.
- History of other malignant tumors (except thyroid cancer and carcinoma in situ) can be included in the study if the individual has remained...
- Patients with acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the...
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chuzhou, Anhui, China
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Ma’anshan, Anhui, China
- Wuhu, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chuzhou, Anhui, China; Fuyang, Anhui, China; Hefei, Anhui, China; Ma’anshan, Anhui, China; Wuhu, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.