Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type Metastatic Colorectal Cancer

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II study was designed to evaluate the efficacy and safety of fruquintinib combination with capecitabine in maintenance treatment after first-line chemotherapy combined with cetuximab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Patients with histologically confirmed metastatic colorectal adenocarcinoma;

• 18-75 years old;

• Eastern Cooperation Oncology Group (ECOG) performance score 0-1;

• At least one evaluable lesion for disease assessment according to RECIST version 1.1;

• Able to take oral medications;

• Patient have achieved CR, PR or SD after up to 8 cycles of first-line standard FOLFOX / - FOLFIRI / XELOX / xeliri + cetuximab treatment, and remained unresectable;

• If radiotherapy has been performed before enrollment, at least one lesion should be located outside the radiation field;

• Adequate organ functions as assessed by the following laboratory requirements:

Leukocytes≥3.0x10^9/L, absolute neutrophil count≥1.5x10^9/L, platelet count≥100x10^9/L, hemoglobin≥9g/dL; serum bilirubin≤1.5x the upper limit of normal(ULN);Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤2.5x ULN; serum creatinine≤1.5x ULN.

• An expected survival of at least 12 weeks;

• Fertile male or female patients volunteered to use effective contraceptive methods during the study period and within 6 months after the end of treatment;

• Willing to provide written informed consent to study procedures.

Exclusion Criteria:

• Patients who have received fruquintinib;

• Patients who have received TACE within 6 weeks before enrollment;

• Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;

• Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;

• International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN；

• The researchers judged clinically significant electrolyte abnormalities;

• At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;

• Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);

• Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);

• Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;

• Uncontrolled central nervous system metastasis or previous brain metastasis;

• Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

• Any kind of concurrent cardiac disease with clinical meanings, such as cardiovascular accident, myocardial infarction, thromboembolism or hemorrhage within 6 months before enrollment, congestive heart failure ≤New York Heart Association (NYHA) class 2; ventricular arrhythmias requiring drug treatment; LVEF < 50%;

• With positive urine protein and 24-hour urinary protein content>1g;

• Have a tendency of bleeding or clotting;

• Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis;

• The target lesions have received brachytherapy (radioactive particle implantation) within 60 days before admission;

• Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment, excluding hair loss, lymphopenia and neurotoxicity ≤ grade 2 caused by oxaliplatin;

• With any illness or medical conditions that may jeopardize the patient's compliance or interfere the analyses or judgements of study results;

• Pregnancy or lactation at the time of study entry;

• With fertility but refuse to contraception.