Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC
- Conditions
- Rectal Cancer
- Interventions
- Registration Number
- NCT05575635
- Lead Sponsor
- Henan Provincial People's Hospital
- Brief Summary
The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment.
- Detailed Description
The study aims to evaluate the efficacy and safety of fruquintinib combined with mFOLFOX6 + synchronous radiotherapy as neoadjuvant therapy in middle and low locally advanced rectal cancer patients with no previous anti-tumor treatment. Approximately 40 patients will be enrolled and undergo combination neoadjuvant therapy, followed by TME and mFOLFOX6 adjuvant therapy, peri-operative treatment will last for 6 months. The primary endpoint is pCR.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Histologically confirmed rectal adenocarcinoma, classified as stage II (T3-4N0) or stage III (T1-4N1-2) by MRI and CT;
- Middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin;
- The multidisciplinary cancer committee recommended neoadjuvant radiotherapy, chemotherapy and surgery;
- ECOG PS 0-1;
- Expected survival ≥ 2 years;
- Have not received any anti-tumor treatment;
- Have at least one measurable lesion;
- Sufficient organs and bone marrow functions;
- Women of childbearing age need to take effective contraceptive measures;
- Patients with surgical contraindication;
- Patients with familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active Crohn's disease or active ulcerative colitis;
- Other malignant tumors found within 5 years before enrollment, except skin basal cell or squamous cell carcinoma, or cervical carcinoma in situ after radical surgery;
- Serious cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurred within 6 months before enrollment;
- International normalized ratio (INR)>1.5 or partially activated prothrombin time (APTT)>1.5 × ULN；
- Investigators judged clinically significant electrolyte abnormalities;
- Hypertension that could not be controlled by drugs before enrollment, which was defined as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
- Poorly controlled diabetes mellitus before enrollment (fasting glucose concentration ≥ CTCAE level 2 after regular treatment);
- Active ulcer of stomach and duodenum, ulcerative colitis and other digestive tract diseases before enrollment, or other conditions that may cause gastrointestinal bleeding and perforation judged by the researcher;
- Serious active bleeding, hemoptysis (>5 mL fresh blood within 4 weeks) or thromboembolism (including stroke and/or transient ischemic attack) occurred within 12 months before enrollment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade>2; Ventricular arrhythmias requiring medication; LVEF<50%;
- Active or uncontrollable serious infection (≥ CTCAE v5.0 grade 2 infection);
- Known human immunodeficiency virus (HIV) infection. A known history of liver disease with clinical significance, including viral hepatitis [People who are known to be carriers of hepatitis B virus (HBV) must exclude active HBV infection, that is, HBV DNA positive (>1 × 104 copies/mL or>2000 IU/ml); Known hepatitis C virus infection (HCV) and HCV RNA positive (>1 × 103 copies/mL);
- Unrelieved toxic reaction caused by any previous anti-cancer treatment higher than CTCAE v5.0 grade 1 or above;
- Routine urine test showed that urinary protein ≥ 2+, and 24-hour urinary protein volume>1.0g.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fruquintinib + mFOLFOX6 + radiotherapy fruquintinib + concurrent radiotherapy + chemotherapy fruquintinib + mFOLFOX6 + radiotherapy
- Primary Outcome Measures
Name Time Method pCR about 2 months pathological complete response rate assessed by the investigator
- Secondary Outcome Measures
Name Time Method MPR about 2 months major pathological response rate assessed by the investigator
ORR about 2 months objective response rate assessed by the investigator
R0 resection rate about 2 months R0 resection rate
DFS about 3 years DFS (Disease-free survival) will be calculated from the date of first administration of study drug to the date of recurrence or death by any reason.
OS about 5 years OS will be calculated from the date of first administration of study drug to the date of death by any reason.
TRAEs about 6 months treatment-related adverse events by CTCAE v5.0