Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

This is an interventional treatment trial for Colo-rectal Cancer focused on measuring fruquintinib, Colo-rectal Cancer, maintenance therapy Read More

Inclusion Criteria:

• 18-75 years old (including 18 and 75 years);
• Eastern Cooperative Oncology Group-performance score (ECOG PS) 0 or 1;
• Estimated survival ≥ 6 months;
• Histologically and/or cytologically confirmed metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer, having unresectable metastatic or recurrent foci;
• Having received first-line systemic anti-tumor therapy for mCRC (chemotherapeutic drugs may include fluorouracil, oxaliplatin, irinotecan, such as XELOX, FOLFOX, FOLFIRI, and can combine or not combine with bevacizumab); achieving RECIST1.1-assessed SD (stable disease) or PR (partial response) or CR (complete response) after 18-24 weeks of first-line treatment.
• UCG suggesting left ventricular ejection fraction ≥50%;
• Having fully understood and voluntarily signed the informed consent.

Exclusion Criteria:

• Absolute neutrophil count (ANC) <1.5×109/L, or platelet count <80×109/L, or hemoglobin < 9g/dL; it's not allowed to perform blood transfusion within 2 week before enrollment to meet the inclusion criteria;
• Serum total bilirubin > 1.5 × upper limit of normal (ULN); > 2.5 × ULN for patients with hepatic metastases;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN, or > 5 × ULN for patients with hepatic metastases;
• Serum creatinine > 1.5 × upper limit of normal (ULN), or creatinine clearance < 50mL / min (calculated using Cockcroft-Gault formula);
• Partial prothrombin time (APTT) or prothrombin time (PT) > 1.5 times ULN (based on the normal value in the clinical study center);
• Clinically significant electrolyte abnormalities;
• Urine protein 2+ or above, or 24-hour urinary protein quantity ≥ 1.0g / 24h;
• Subjects with dysphagia or known drug absorption disorders;
• Presence of brain metastasis or leptomeningeal metastasis;
• The toxicity of previous anticancer treatment has not yet reduced to (NCI CTC AE) level 1, excluding alopecia and oxaliplatin-induced neurotoxicity ≤ 2); patients haven't not fully recovered from previous surgery or less than 4 weeks elapsed since previous anticancer treatment or surgery;
• Patients have clinically detectable second primary malignant tumors at enrollment, or have other malignant tumors (except for well-treated basal cell carcinoma or cervical carcinoma in situ) in the past 5 years;
• Patients have clinically uncontrolled active infections such as acute pneumonia, hepatitis B or hepatitis C activity (previous history of hepatitis B infection, whether or not under medication control, HBV DNA ≥ 104 copies or ≥ 2000 IU/ml);
• Patients have hypertension that cannot be controlled by a single drug. That is, after single drug treatment, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
• Patients currently have digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction or other conditions that may cause gastrointestinal bleeding or perforation at the discretion of the investigator; or patients have undergone surgery for intestinal perforation and intestinal fistula but was uncured.
• Patients have a history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or patients have bleeding tendency or bleeding history within the 2 months before enrollment, regardless of severity;
• Patients have a stroke or transient ischemic attack within 12 months prior to enrollment;
• Skin wounds, surgical sites, trauma site, severe mucosal ulcers or fractures haven't completely healed yet.
• Patients have acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting or NYHA Class II/more severe cardiac insufficiency within 6 months prior to enrollment;
• Pregnant or lactating women; or women with potentiality of childbearing have a positive pregnancy test result before the first dose;
• Patients have any clinical or laboratory abnormalities or compliance problems so that the investigator believes that they are not suitable to participate in this clinical study;
• Patients have serious psychological or mental abnormalities;