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Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

A Single-arm, Open, Multicenter Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

NCT06118762•The First Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy

Detailed Description

To evaluate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Raltitrexed in 30 patients with metastatic colorectal cancer who had progressed or could not tolerate fluorouracil, oxaliplatin, and irinotecan based therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have fully understood the study and voluntarily signed the informed consent;
•2. Age ≥18 years old, gender unlimited;
•3. Advanced metastatic colorectal adenocarcinoma confirmed by histopathology;
•4. The patient progressed or was intolerant after receiving at least previous standard therapy containing fluorouracil, oxaliplatin, and irinotecan.
•* Each first-line treatment must include one or more chemotherapeutic agents for a duration of ≥1 cycle;
•* Allow pre-adjuvant/neoadjuvant therapy. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for advanced disease;
•* Prior chemotherapy combined with cetuximab or bevacizumab is permitted;
•5. Have at least one measurable lesion (RECIST 1.1 standard);
•6. Eastern Cooperative Oncology Group (ECOG) physical condition 0-1 score;
•7. Expected survival ≥12 weeks;
+9 more criteria

Exclusion Criteria

•1. Previous treatment with Fruquintinib or other anti-vascular endothelial growth factor receptor (VEGFR) inhibitors such as Apatinib, Regorafenib, and Anlotinib;
•2. Previous treatment with Raltitrexed;
•3. Participated in other drug clinical trials and received at least one drug therapy within four weeks prior to enrollment or received other systemic anti-tumor therapy, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks prior to enrollment;
•4. The patient currently has a disease or condition that affects drug absorption, or the patient cannot take Fruquintinib orally;
•5. The patient currently has gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation;
•6. Patients with active bleeding or bleeding tendency;
•7. History of severe cardiovascular and cerebrovascular diseases:
•* Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina, and poorly controlled arrhythmias (including QTc interval ≥ 450ms for men and 470 ms for women) within 6 months prior to first administration of the study drug (QTc interval Fridericia) Formula calculation);
•* New York Heart Association (NYHA) Heart Function Rating \> Grade II or left ventricular ejection fraction (LVEF) \< 50%;
•8. Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
+6 more criteria

Locations (1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

October 20, 2023

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

November 7, 2023

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Fruquintinib

DRUG

Contacts

Xiaodong Peng, Director

CONTACT

0086-457-079186427246 pxddhbb@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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