Neoadjuvant Treatment of Fruquintinib Combined With Concurrent Chemoradiotherapy for LARC

NCT05575635 | Unknown Phase 2

• 1 other identifier: HMPL-013-FLAG-C121
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Cancer

Keywords

neoadjuvant; peri-operative

Outcome Measures

Primary Outcomes (1)

• pCR

  pathological complete response rate assessed by the investigator

  about 2 months

Secondary Outcomes (6)

• MPR

  about 2 months

• ORR

  about 2 months

• R0 resection rate

  about 2 months

• DFS

  about 3 years

• OS

  about 5 years

Study Arms (1)

fruquintinib + mFOLFOX6 + radiotherapy

EXPERIMENTAL

fruquintinib + mFOLFOX6 + radiotherapy

Drug: fruquintinib + concurrent radiotherapy + chemotherapy

Interventions

fruquintinib + concurrent radiotherapy + chemotherapy DRUG

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 + mFOLFOX6 + radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

HMPL-013; Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Mingyue Liu, M.D.

CONTACT

18638927799; liumingyuezz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10