Fruquintinib Plus S-1 and Raltitrexed (RSF) for mCRC
- Conditions
- Interventions
- Registration Number
- NCT06427005
- Lead Sponsor
- West China Hospital
- Brief Summary
Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic c...
- Detailed Description
Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and ant...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
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Age ≥ 18 years, any gender.
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Patients with metastatic colorectal adenocarcinoma confirmed by pathological histology or cytology.
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Expected survival time ≥ 12 weeks.
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ECOG score of 0-2.
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Previously treated for metastatic colorectal cancer with fluoropyrimidine (allowing intravenous and/or oral fluoropyrimidine formulations, excluding DPD enzyme inhibitors), irinotecan, and oxaliplatin chemotherapy, which failed (treatment failure defined as intolerable adverse reactions, disease progression during treatment, or disease progression within 6 months after completing adjuvant chemotherapy); regardless of prior use of targeted drugs such as cetuximab or bevacizumab.
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Patients must have an interval of at least 2 weeks since the last chemotherapy (at least 1 week for oral chemotherapy drugs) or more than 4 weeks since the end of radiotherapy, with the study's observable lesions located outside the radiotherapy target area.
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According to RECIST 1.1 criteria, at least one measurable tumor lesion with a maximum diameter ≥ 1 cm as determined by spiral CT scan.
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Laboratory test results within 1 week before enrollment must meet the following criteria:
- Hemoglobin ≥ 90 g/L; Platelets (PLT) ≥ 75 × 10^9/L;
- White blood cells (WBC) ≥ 3.0 × 10^9/L; Neutrophils (ANC) ≥ 1.5 × 10^9/L;
- Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN);
- Total bilirubin (TBI) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if there is liver metastasis).
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No prior use of raltitrexed or S-1 (or DPD enzyme inhibitors) in the treatment of colorectal cancer.
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Signed informed consent.
- Patients unable to take oral medications.
- Patients who have previously been treated with small molecule TKI drugs.
- Patients with severe hepatic or renal insufficiency, or a recent history of myocardial infarction (within 3 months).
- Patients with a history of other malignancies within the past five years, except for cured cervical carcinoma in situ and basal cell carcinoma of the skin.
- Patients with a history of inflammatory bowel disease or extensive colonic resection, ≥50% or extensive small bowel resection with chronic diarrhea, or intestinal obstruction.
- Patients with severe uncontrolled internal medical conditions or acute infections (fever > 38°C due to infection).
- Patients with symptomatic brain or leptomeningeal metastases (unless the patient has been treated for brain or leptomeningeal metastases > 6 months, with negative imaging results within 4 weeks before study entry, and has stable clinical symptoms related to brain or leptomeningeal metastases at study entry).
- Patients with clinically significant, uncontrolled pleural effusion or ascites despite clinical intervention.
- Pregnant or breastfeeding women, or patients of reproductive potential (males or females not in menopause for less than 1 year) unwilling to use contraception.
- Patients known to be allergic to raltitrexed, S-1, and Fruquintinib or any of their components.
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RSF treatment arm Fruquintinib Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. RSF treatment arm raltitrexed Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. RSF treatment arm S-1 Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks.
- Primary Outcome Measures
Name Time Method ORR about a year Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
- Secondary Outcome Measures
Name Time Method OS about a year OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Safety and tolerability about a year Version 5.0 and AEs leading to dose interruption or discontinuation.
DCR about a year Disease Control Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Trial Locations
- Locations (2)
Sichuan University West China Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China