2025-521319-38-00尚未招募2 期
A phase II, open label, multicenter trial investigating Irinotecan plus cetuximab rechallenge compared with trifluridine/tipiracil plus bevacizumab as third line treatment in circulating tumor DNA molecularly selected metastatic colorectal cancer: the ROMANCE-GOIM trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 26
- 主要终点
- ORR by RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator
研究概览
简要总结
The primary objective is to demonstrate the superiority of irinotecan plus cetuximab compared with trifluridine/tipiracil plus bevacizumab in terms of ORR.
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
- 是
入选标准
- •Male or female aged ≥18 years
- •RAS/BRAF/EGFR/PIK3CAex20/ MAP2K1/MET WT and HER2 not amplified ctDNA at FoundationOne CDx test at baseline.
- •Life expectancy of at least 3 months.
- •Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).
- •Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all subjects or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
- •Adequate renal function defined by an estimated creatinine clearance > 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- •No contraindication to the study drugs.
- •No prior treatment with trifluridine/tipiracil.
- •Women of childbearing potential* must have a negative blood pregnancy test at thescreening visit. Subjects and their partners must be willing to avoid pregnancy during the trial. *A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •Women of childbearing potential, or male, must agree to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate.
- •Will and ability to comply with the protocol.
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1
- •Signed informed consent obtained before screening.
- •Diagnosis of histologically or cytologically confirmed colorectal cancer.
- •At least one measurable lesion according to RECIST1.1
- •KRAS/NRAS/BRAFV600E wt status of primary CRC or related metastasis (local laboratory assessment).
- •Progression to previous first-line anti-EGFR-containing therapy producing at least a partial response ≥ 6 months.
- •Received and progressed to an anti-EGFR and irinotecan free second-line treatment.
- •Have an anti-EGFR free interval of at least 4 months.
- •Refractory to previous 5-fluorouracil/capecitabine, irinotecan, oxaliplatin, bevacizumab.
排除标准
- •Diagnosis of interstitial pneumonitis or pulmonary fibrosis.
- •History of abdominal fistula, GI perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to the first study treatment.
- •Pregnant or lactating women.
- •Psychiatric or addictive disorders would preclude study participation.
- •Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study treatments.
- •Withdrawal of the consent to take part to the study.
- •Received more than 2 lines of treatment for metastatic disease.
- •Previous treatment with trifluridine/tipiracil
- •RAS/BRAF/EGFR/PIK3CAex20/ MAP2K1/MET alterations and HER2 amplified tumors at liquid biopsy analysis during screening
- •Previous history of malignancy within the last 2 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
- •Evidence of bleeding diathesis or coagulopathy.
- •Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
- •Known severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
- •Clinically significant cardiovascular disease, active inflammatory bowel disease, active autoimmune disease.
结局指标
主要结局
ORR by RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator
ORR by RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator
次要结局
- 1. PFS defined as the time from random assignment in the clinical trial to disease progression or death from any cause.
- 2. OS defined as the interval from enrollment to death for every cause.
- 3. The safety profile of the trial drugs as measured by the incidence of AEs evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS
- 4. Quality of life (QoL) questionnaire (EORTC QLQ-C30)
研究者
Davide Ciardiello
Scientific
Gruppo Oncologico Dell'Italia Meridionale
研究点 (26)
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