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Status:

RECRUITING

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

Lead Sponsor:

Sun Yat-sen University

Conditions:

Colorectal Cancer Metastatic

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

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, b...

Eligibility Criteria

Inclusion

  • . 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 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；
  • .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.
  • . 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.

Exclusion

  • .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 \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (\>1×104 copies/mL or \>2000 IU/mL)\]. c) Known hepatitis C virus (HCV) infection with positive HCV RNA (\>1×103 copies/mL), or other hepatitis, liver cirrhosis.
  • .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.

Key Trial Info

Start Date :

May 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT06018714

Start Date

May 1 2023

End Date

August 1 2026

Last Update

August 31 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Colorectal Department,SunYat-sen University Cancer Center

Guangzhou, Guangdong, China, 510062

Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study | DecenTrialz