Actively Recruiting
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Led by Sun Yat-sen University · Updated on 2023-08-31
64
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall 5-year survival rate for patients with colorectal liver metastases (CRLM) is still less than 20%. Surgery-based local treatment can achieve no evidence of disease (NED) in CRLM patients, but over 60% of patients experience recurrence even after achieving NED. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The Chinese Society of Clinical Oncology (CSCO) guidelines have recommended fruquintinib as a third-line therapy for colorectal cancer. This study aims to evaluate the effectiveness and safety of fruquintinib as a maintenance therapy for patients with advanced colorectal cancer (CRC) who have achieved no evidence of disease (NED) after completing adjuvant chemotherapy.
CONDITIONS
Official Title
Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of colorectal adenocarcinoma liver metastasis
- Age between 18 and 75 years, all genders
- Previously received first-line chemotherapy with disease control (partial response or stable disease) per RECIST 1.1
- Underwent curative local treatment (surgery, ablation, SBRT) for liver metastases and achieved no evidence of disease (NED) confirmed by imaging or biopsy
- Completed adjuvant chemotherapy after achieving NED (e.g., 4-8 cycles CapOX, 6-12 cycles FOLFOX) or no recent adjuvant chemotherapy, with last chemotherapy within 2 months before enrollment
- Time interval between last chemotherapy and enrollment not exceeding 2 months
- Performance status (ECOG) score of 2 or less
- Hematology: WBC > 3 × 10^9 /L; Platelets > 80 × 10^9 /L; Hemoglobin > 90 g/L
- Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); bilirubin ≤ 1.5 × ULN
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml/min
- Signed informed consent and willingness to comply with study treatment and protocol
You will not qualify if you...
- Tumor progression before enrollment after completing chemotherapy
- Intestinal obstruction or incomplete intestinal obstruction
- Presence of other serious illnesses such as severe electrolyte disorders or bleeding tendencies
- Active or uncontrolled severe infections including HIV infection, active hepatitis B or C infection, liver cirrhosis
- Pregnant or breastfeeding women who are not using adequate contraception
- Severe brain disorders or mental illnesses affecting ability to self-report
- Autoimmune diseases, blood system disorders, history of organ transplantation, or long-term use of steroids or immunosuppressants
- History of other cancers within the past 5 years except cured cervical carcinoma in situ or basal cell skin carcinoma
- Known or suspected allergy to fruquintinib
- Poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Active cardiac disease in past 6 months including myocardial infarction, unstable angina, or poor heart function (ejection fraction <50%)
- Significant proteinuria (urine protein ≥2+ or 24-hour urine protein >1.0g)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Colorectal Department,SunYat-sen University Cancer Center
Guangzhou, Guangdong, China, 510062
Actively Recruiting
Research Team
J
Junzhong Lin, Doctor
CONTACT
Z
Zhizhong Pan, Prof
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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