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

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fruquintinib to see how effective and safe it is as a maintenance therapy for patients with metastatic colorectal cancer (cancer that has spread beyond the colon) after they have completed their first round of treatment. The trial is specifically looking for adults aged 18 to 75 who have certain types of colon cancer and have responded positively to their initial treatment, meaning their cancer has either stabilized or improved. It aims to include around 110 participants who will be divided into two groups: one will receive fruquintinib, while the other will be monitored without the medication.

If you or a loved one qualifies for this study, you can expect to be involved for about two years, with regular check-ins to monitor your health and response to the treatment. Participants will be closely watched for any side effects, and the trial will help determine if fruquintinib is a beneficial option for maintaining health after initial cancer treatment. It's important to know that there are specific health criteria that need to be met to join, such as having stable blood counts and no active infections. This trial is currently recruiting participants, so it's a good opportunity for those looking for additional treatment options.

Gender

ALL

Eligibility criteria

• 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;