NCT07261709尚未招募2 期
Trifluridine/Tipiracil Plus Fruquintinib vs. Trifluridine/Tipiracil Plus Bevacizumab in Refractory Metastatic Colorectal Cancer: A Randomized, Controlled, Open-Label, Non-Inferiority Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study is an investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial designed to evaluate the efficacy and safety of trifluridine/tipiracil plus fruquintinib versus trifluridine/tipiracil plus bevacizumab in the treatment of refractory metastatic colorectal cancer.
详细描述
A total of 236 patients will be enrolled in this investigator-initiated, prospective, multicenter, randomized, controlled, open-label, non-inferiority trial.
Experimental group:
Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus fruquintinib 4 mg orally once daily for 3 weeks followed by 1 week off, repeated every 4 weeks.
Control group:
Trifluridine/tipiracil 35 mg/m² orally twice daily on days 1-5 and 8-12, repeated every 4 weeks, plus bevacizumab 5 mg/kg intravenously on day 1 every 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All study participants must sign the informed consent form before any study-related procedures are initiated.
- •Aged 18-75 years, both males and females.
- •Histologically confirmed unresectable colorectal cancer.
- •RAS status known (mutant or wild-type).
- •Progression or intolerance after at least two prior systemic regimens that must have contained fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti-VEGF therapy and/or anti-EGFR therapy.
- •At least one measurable lesion per RECIST v1.
- •Able to swallow oral tablets or capsules.
- •Estimated life expectancy ≥ 12 weeks.
- •ECOG performance status 0-
- •Adequate major organ function (within 7 days before randomization):
- •Absolute neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 75 × 10⁹/L Hemoglobin ≥ 90 g/L (no transfusion within 7 days) Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) Total bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases present) Urinalysis showing proteinuria ≤ 1+ or 24-h urine protein < 1 g INR or PT ≤ 1.5 × ULN (acceptable if on anticoagulation and PT within intended therapeutic range)
- •Women of child-bearing potential must have a negative serum pregnancy test within 7 days before randomization; all participants and their partners must agree to use highly effective contraception from screening through at least 6 months after the last dose of study medication.
排除标准
- •1.Prior treatment with trifluridine/tipiracil, fruquintinib, or any other VEGF-receptor tyrosine-kinase inhibitor (e.g., apatinib, regorafenib, anlotinib).
- •2.Pregnant or lactating women, or women who may become pregnant during the study.
- •3.Anti-cancer therapy given ≤ 4 weeks before randomization (or not yet completed).
- •4.Clinically relevant non-haematological CTCAE grade ≥ 3 toxicity from prior anti-cancer therapy that has not resolved to ≤ grade 1 (except alopecia and skin pigmentation).
- •5.Symptomatic central-nervous-system metastases, unstable neurological status, or requirement for an increased steroid dose to control CNS disease.
- •6.Severe or uncontrolled acute or chronic active infection. 7.History of active or interstitial lung disease, pneumonitis, or pulmonary arterial hypertension.
- •8.Clinically significant active hepatitis of any cause, including but not limited to hepatitis B or C.
- •9.Known HIV-positive status. 10.Uncontrolled hypertension (systolic BP ≥ 150 mmHg and/or diastolic BP ≥ 100 mmHg), uncontrolled arrhythmia, or symptomatic arrhythmia.
- •11.Arterial thrombo-embolic event ≤ 6 months before randomization, including cerebrovascular accident or myocardial infarction.
- •12.Major surgery ≤ 4 weeks before randomization (surgical incision must be fully healed before study drug administration), not yet recovered from previous surgery, or major surgery anticipated during the study.
- •13.Radiotherapy ≤ 2 weeks before randomization, except short-course palliative radiotherapy for symptom relief.
- •14.Any other clinically significant medical condition that, in the investigator's opinion, would compromise patient safety or study integrity.
- •15.Concurrent or previous malignancy within 5 years, except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
研究组 & 干预措施
Trifluridine/tipiracil plus fruquintinib
Experimental
干预措施: Trifluridine/tipiracil plus fruquintinib (Drug)
Trifluridine/tipiracil plus bevacizumab
Active Comparator
干预措施: trifluridine/tipiracil plus bevacizumab (Drug)
结局指标
主要结局
PFS
时间窗: Time from the date of randomization to the first occurrence of disease progression (as assessed by the investigator according to RECIST v1.1) or death, whichever occurs first,up to 2 years
Progression-free Survival
次要结局
- OS(Time from the date of randomization to death from any cause up to 3 years)
- ORR(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
- DCR(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
- Safety and tolerance(from first dose to within 30 days after the last dose)
研究者
Peng Jian-jun
Professor
Sun Yat-sen University
研究点 (1)
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