Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC

Trial Title: Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC

NCT ID: NCT05575635

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
neoadjuvant
peri-operative

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: fruquintinib + concurrent radiotherapy + chemotherapy
Description: mFOLFOX6: The mFOLFOX6 regimen will be administered on Day 1 of each treatment cycle. This regimen consists of oxaliplatin 85 mg/m2 IV given over 2 hours, leucovorin 400 mg/m2 IV given over 2 hours, and fluorouracil 400 mg/m2 IV bolus, followed by fluorouracil 1200 mg/m2 per day for 2 days, continuous infusion. fruquintinib: 3mg/d, qd po, for 7 weeks continuously. Radiation Therapy: radiation 45.0~50.0 Gy (1.8-2.0 Gy/day or 25 fractions weeks 3-7)
Arm group label: fruquintinib + mFOLFOX6 + radiotherapy

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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; Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: November 2022

Completion date: November 2025

Lead sponsor:
Agency: Henan Provincial People's Hospital
Agency class: Other

Source: Henan Provincial People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05575635