2024-512555-21-00招募中3 期
A randomized phase III trial assessing a regorafenib-irinotecan combination (REGIRI) versus regorafenib alone in metastatic colorectal cancer patients after failure of standard therapies, according to the A/A genotype of Cyclin D1.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 11
- 主要终点
- Overall survival presented with its median and confidence interval at 95%, estimated from randomization date to the date of death, whatever the cause, using the Kaplan-Meier method.
研究概览
简要总结
Comparison of overall survival in the Regorafenib and REGIRI combination (Regorafenib + Irinotecan) arms in mCRC patients of Cyclin D1 A/A genotype.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histological documentation of adenocarcinoma of the colon or rectum
- •Patients with metastatic colorectal cancer
- •Progression during or within 3 months following the last administration of approved standard therapies, which must include a fluoropyrimidine (or raltitrexed), oxaliplatin, irinotecan, anti-VEGF therapy and an anti-EGFR therapy (for RAS wild-type tumors), encorafenib
- •ECOG performance status ≤1
- •Life expectancy of at least 3 months
- •Patients with A/A CCND1 genotype of rs603965 CCND1
- •International normalized ratio (INR) ≤ 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant, e.g., heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care
排除标准
- •Patients with A/G or G/G CCND1 genotype of rs603965 CCND1
- •Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management)
- •Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE V5.0 Grade 2 dyspnea)
- •Ongoing infection > Grade 2 NCI-CTCAE V5.0
- •Known history of human immunodeficiency virus (HIV) infection
- •Active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy
- •Patients with seizure disorder requiring medication
- •History of organ allograft
- •Patients with evidence or history of any bleeding diathesis, irrespective of severity
- •Any hemorrhage or bleeding event ≥ NCI-CTC V5.0 Grade 3 within 4 weeks prior to the start of study medication
- •Non-healing wound, ulcer, or bone fracture
- •Prior treatment with regorafenib or sorafenib
- •Dehydration NCI-CTCAE V5.0 Grade ≥ 1
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
- •Persistent proteinuria of NCI-CTCAE V5.0 Grade 3 (> 3.5g/24 hours)
- •Patients unable to swallow oral medications
- •Any malabsorption condition
- •Chronic inflammatory bowel disease and / or bowel obstruction
- •Unresolved toxicity higher than NCI-CTCAE V.5.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity ≤ Grade 2
- •Concomitant intake of St. John's wort
- •History of gastrointestinal fistula or perforation
- •Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)].
- •Prior treatment with TAS 102
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
- •Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug
- •Congestive heart failure ≥ New York Heart Association (NYHA) class 2
- •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months)
- •Myocardial infarction less than 6 months before start of study drug
- •Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
结局指标
主要结局
Overall survival presented with its median and confidence interval at 95%, estimated from randomization date to the date of death, whatever the cause, using the Kaplan-Meier method.
Overall survival presented with its median and confidence interval at 95%, estimated from randomization date to the date of death, whatever the cause, using the Kaplan-Meier method.
次要结局
- Progression-free survival (PFS)
- Time to Deterioration
- Disease control rate
- Objective response rate
- Safety according version 5 of NCI-CTCAE
- Quality of life (EORTC QLQ-C30)
研究者
Project manager
Scientific
Institut Regional Du Cancer De Montpellier
研究点 (11)
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