Fruquintinib for Colorectal Cancer Liver Metastases
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Recruiting
Phase 2Interventional Study
Colorectal Cancer Metastatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
64 (estimated)
Sponsor
Sun Yat-sen University · Other
Who this trial is looking for
This trial is looking for patients with colorectal cancer that has spread to the liver and who have shown no signs of cancer after treatment. Participants will take fruquintinib as a maintenance therapy to help prevent cancer from coming back.
Are You a Good Fit for This Trial?
You may be able to join if
I have colorectal adenocarcinoma liver metastasis.
I am between 18 and 75 years old.
I have had disease control after first-line chemotherapy.
I have had local treatment and achieved no evidence of disease (NED).
I completed adjuvant chemotherapy after achieving NED within the last 2 months.
My performance status is ECOG ≤ 2.
My blood counts are within required limits.
My liver and kidney functions are within normal limits.
You may not be able to join if
I have had tumor progression after chemotherapy.
I have intestinal obstruction.
I have other serious illnesses affecting my health.
I have active or uncontrolled severe infections.
I am pregnant or breastfeeding without proper birth control.
I have severe brain disorders or mental illnesses.
I have autoimmune diseases or a history of organ transplantation.
I have high blood pressure that is not well controlled.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquinti…
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. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The Chinese Society of Clinical Oncology (CSCO) guidelines have recommended fruquintinib as a third-line therapy for colorectal cancer. This study aims to evaluate the effectiveness and safety of fruquintinib as a maintenance therapy for patients with advanced colorectal cancer (CRC) who have achieved no evidence of disease (NED) after completing adjuvant chemotherapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. . The pathological diagnosis was colorectal adenocarcinoma liver metastasis;
2. . Age: 18 to 75 years old,allgenders;
3. . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
4. . Patients with liver…
Inclusion Criteria:
1. . The pathological diagnosis was colorectal adenocarcinoma liver metastasis;
2. . Age: 18 to 75 years old,allgenders;
3. . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
4. . 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 residual signs of primary or metastatic tumors are observed on CT, MRI, PET-CT imaging, or b. No cancer cells are found in biopsies of suspicious lesions;
5. .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 chemotherapy within 2 months from enrollment.
6. . The time interval between the last chemotherapy and enrollment does not exceed 2 months;
7. . Performance status (ECOG score) ≤ 2
8. . Hematology: WBC \> 3 × 10\^9 / L; PLT \> 80 × 10\^9 / L; Hb \> 90 g/L;
9. . Liver function: ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN;
10. .Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;
11. .Signed informed consent, willingness to undergo treatment according to this protocol, and good compliance with medication.
Exclusion Criteria:
1. .Patients with tumor progression before enrollment following the completion of chemotherapy.
2. .Intestinal obstruction or incomplete intestinal obstruction.
3. .Co-existing with other serious illnesses, including severe electrolyte disorders, bleeding tendencies, etc.
4. .Active or uncontrolled severe infections: a) Known human immunodeficiency virus (HIV) infection. b) Known clinically significant liver disease history, including viral hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>1×104 copies/mL or \>2000 IU/mL)\]. c) Known hepatitis C virus (HCV) infection with positive HCV RNA (\>1×103 copies/mL), or other hepatitis, liver cirrhosis.
5. .Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
6. .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.
7. .Patients with autoimmune diseases, blood system disorders, and a history of organ transplantation, long-term use of steroids, or immunosuppressive agents.
8. .History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.
9. .History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation).
10. .Known or suspected allergies to the investigational drug fruquintinib.
11. .Hypertension that cannot be well controlled with antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
12. .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.
13. .Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification \>1.0g.
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