Recruiting PHASE2 Colorectal Cancer Metastatic

Tests treatment safety and results for Colorectal Cancer Metastatic

Official title Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study

ClinicalTrials.gov ID: NCT06018714

What this study is testing

What is Fruquintinib?

Fruquintinib is an investigational medicine, being studied as a potential treatment for colorectal cancer metastatic.

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 overall 5-year survival rate for patients with colorectal liver metastases (CRLM) is still less than 20%. Surgery-based local treatment can achieve no evidence of disease (NED) in CRLM patients, but over 60% of patients experience recurrence even after achieving NED.
  • Phase 2: a mid-size study of how well it works

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 75

You may be able to join if

  • . The pathological diagnosis was colorectal adenocarcinoma liver metastasis；
  • . Age: 18 to 75 years old,allgenders；
  • . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
  • . Patients with liver metastasis of colorectal cancer who have undergone curative local treatment (surgery, ablation, SBRT) and achieved no evidence...
  • .Completed adjuvant chemotherapy after achieving NED (e.g. 4-8 cycles of CapOX regimen, 6-12 cycles of FOLFOX regimen, or without receiving adjuvant...

You likely can't join if

  • .Patients with tumor progression before enrollment following the completion of chemotherapy.
  • .Intestinal obstruction or incomplete intestinal obstruction.
  • .Co-existing with other serious illnesses, including severe electrolyte disorders, bleeding tendencies, etc.
  • .Active or uncontrolled severe infections: a) Known human immunodeficiency virus (HIV) infection. b) Known clinically significant liver disease...
  • .Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
  • .Patients with severe brain disorders or mental illnesses (such as depression, mania, obsessive-compulsive disorder, and schizophrenia) that affect...
See the full eligibility criteria
Who can join
  • . The pathological diagnosis was colorectal adenocarcinoma liver metastasis；
  • . Age: 18 to 75 years old,allgenders；
  • . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
  • . Patients with liver metastasis of colorectal cancer who have undergone curative local treatment (surgery, ablation, SBRT) and achieved no evidence of disease (NED). Definition of NED: a. After local treatment, no...
  • .Completed adjuvant chemotherapy after achieving NED (e.g. 4-8 cycles of CapOX regimen, 6-12 cycles of FOLFOX regimen, or without receiving adjuvant chemotherapy recently) and evaluated as no disease progression. Last...
  • . The time interval between the last chemotherapy and enrollment does not exceed 2 months;
  • . Performance status (ECOG score) ≤ 2
  • . Hematology: WBC \> 3 × 10\^9 / L; PLT \> 80 × 10\^9 / L; Hb \> 90 g/L;
  • . Liver function: ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN;
  • .Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;
  • .Signed informed consent, willingness to undergo treatment according to this protocol, and good compliance with medication.
What rules you out
  • .Patients with tumor progression before enrollment following the completion of chemotherapy.
  • .Intestinal obstruction or incomplete intestinal obstruction.
  • .Co-existing with other serious illnesses, including severe electrolyte disorders, bleeding tendencies, etc.
  • .Active or uncontrolled severe infections: a) Known human immunodeficiency virus (HIV) infection. b) Known clinically significant liver disease history, including viral hepatitis [known carriers of hepatitis B virus...
  • .Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
  • .Patients with severe brain disorders or mental illnesses (such as depression, mania, obsessive-compulsive disorder, and schizophrenia) that affect the patient's ability to self-report.
  • .Patients with autoimmune diseases, blood system disorders, and a history of organ transplantation, long-term use of steroids, or immunosuppressive agents.
  • .History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.
  • .History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation).
  • .Known or suspected allergies to the investigational drug fruquintinib.
  • .Hypertension that cannot be well controlled with antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
  • .Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction \<50% on echocardiography, poorly controlled arrhythmias.
  • .Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification \>1.0g.

The study team makes the final eligibility decision.

Where it's taking place

  • Guangzhou, Guangdong, 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 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.

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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.