Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Leucovorin

Fluorouracil

Oxaliplatin

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)

fruquintinib + concurrent radiotherapy + chemotherapy

Mingyue Liu, M.D.

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.

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.

Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC

A Single Arm, Single Center Clinical Study of Fruquintinib Combined With Concurrent Chemoradiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

pathological complete response rate assessed by the investigator

major pathological response rate assessed by the investigator

objective response rate assessed by the investigator

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 will be calculated from the date of first administration of study drug to the date of death by any reason.

treatment-related adverse events by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC	NCT05575635	Rectal Cancer	fruquintinib + ...	18 Years - 75 Years	Henan Provincial People's Hospital
Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC	NCT05575635	Rectal Cancer	fruquintinib + ...	18 Years - 75 Years	Henan Provincial People's Hospital

Spots Global Cancer Trial Database for fruquintinib + concurrent radiotherapy + chemotherapy