Actively Recruiting
Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer
Led by The First Affiliated Hospital of Nanchang University · Updated on 2023-11-07
30
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older, any gender
- Advanced metastatic colorectal adenocarcinoma confirmed by histopathology
- Disease progression or intolerance after prior fluorouracil, oxaliplatin, and irinotecan based chemotherapy
- At least one measurable lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate vital organ function within 14 days before enrollment, including specified blood counts and liver/kidney function
- Women of childbearing age and men with partners desiring children must use effective contraception
- Prior first-line treatment must include at least one chemotherapy cycle; prior chemotherapy with cetuximab or bevacizumab allowed
- Pre-adjuvant/neoadjuvant therapy allowed; recurrence/metastasis during or within 6 months of such therapy considered treatment failure
You will not qualify if you...
- Previous treatment with Fruquintinib or other VEGFR inhibitors such as Apatinib, Regorafenib, or Anlotinib
- Previous treatment with Raltitrexed
- Participation in other drug clinical trials or systemic anti-tumor therapy within 4 weeks prior to enrollment
- Conditions affecting drug absorption or inability to take oral Fruquintinib
- Active gastrointestinal diseases such as ulcers, ulcerative colitis, or bleeding from unresectable tumors
- Active bleeding or bleeding tendencies
- Severe cardiovascular or cerebrovascular diseases within 6 months prior to study drug administration
- New York Heart Association Heart Function Class greater than II or left ventricular ejection fraction below 50%
- Other malignancies within 5 years except certain skin or cervical cancers
- Uncontrolled active infections, including active hepatitis B or C
- Symptomatic central nervous system metastases or cancerous meningitis (exceptions for stable treated brain metastases)
- Pregnant or breastfeeding women
- Uncontrolled hypertension despite medication
- Urine protein levels of 2+ or higher, or 24-hour urinary protein over 1.0g
- Any condition deemed unsuitable for study participation by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
X
Xiaodong Peng, Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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