2024-514030-20-00尚未招募2 期
ENGIC - 01 COLOSOTO: A single-arm phase II study evaluating 5-fluorouracil plus Panitumumab (anti-EGFR) and Sotorasib (KRAS G12C inhibitor) in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma
Fondation Franc.Cancerologie Digestive80 个研究点 分布在 2 个国家目标入组 37 人开始时间: 2025年3月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 80
- 主要终点
- The rate of patients alive without progression 8 months after the inclusion.
研究概览
简要总结
Progression-free survival of under 5-fluorouracil plus Panitumumab and Sotorasib (KRAS G12C inhibitor) at 8 months in first-line treatment of patients non-eligible for a doublet/triplet chemotherapy with advanced unresectable KRAS G12C mutated colorectal adenocarcinoma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Provides written informed consent for the study.
- •Life expectancy >6 months
- •Women of childbearing potential must agree to use contraception during the trial treatment and for at least 6 months after discontinuation of the experimental treatments. Men who have sexual relationship with women of childbearing potential must agree to use contraception during treatment and for at least 3 months after discontinuation of the experimental treatments
- •Patient affiliated to a social security scheme for France, or equivalent for other countries
- •Histologically proven advanced-stage unresectable locally advanced or metastatic colorectal adenocarcinoma
- •Agreement to participate to biological studies (blood samples for ctDNA and send tumour block).
- •Patient unfit for doublet/triplet regimen: Frail patients (WHO PS=2),patient between 70 and 75 years old with WHO PS 1 - 2, patient ≥ 75 years old with WHO PS 0-2
- •Proven KRAS G12C mutation as locally assessed by means of a IVDR compliant test.
- •Measurable lesion according to the Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1).
- •No prior treatment for the metastatic disease. Prior adjuvant chemotherapy is allowed.
- •Adequate organ function: Hemoglobin > 9 g/dl, Absolute neutrophil count > 1500 /mm3, Platelets > 80 000/mm3, Creatinine clearance rate ≥50 mL/min as calculated using MDRD formula, ALT/AST ≤5×ULN and total bilirubin ≤1.5×ULN.
- •Ability to understand and sign written informed consent to participate in the study.
排除标准
- •Uncontrolled intercurrent illness including liver (liver cirrhosis Child Pugh B or C) and lung (one second forced expiratory volume <50%) severe insufficiency
- •Patient with interstitial lung disease or pulmonary fibrosis
- •Has a known psychiatric or substance abuse disorder that would interfere with the patient’s ability to cooperate with the requirements of the study
- •Patient who is under judicial protection and patient who is legally institutionalized or under guardianship or not able to give consent
- •Pregnant or breastfeeding woman
- •Inability to undergo the medical follow-up of the trial for geographical, social or psychological reasons
- •Clinically significant cardiac abnormalities including prior history of any of the following: severe cardiomyopathy, congestive heart failure of New York Heart Association grade ≥3, history of clinically significant (i.e., active) atherosclerotic cardiovascular disease (myocardial infarction, unstable angina, cerebrovascular accident within 6 months prior to the first dose of study treatments)
- •Patients with Dihydropyrimidine Dehydrogenase (DPD) enzyme deficiencies (uracilemia ≥ 16 ng/mL)
- •Immunotherapy within 3 months before the beginning of the treatment study
- •Patient under treatment by strong CYP3A4 inducers
- •Other malignancy within 2 years prior to study enrolment, except for localized cancer in situ, basal or squamous cell skin cancer adequately treated
- •Less than 4 weeks from major surgeries and not recovered adequately from the procedure and/or any complications from the surgery
- •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks or 5 half-lives (whichever longer) before study entry
- •Hypersensitivity to one of the active substances or to one of the excipients of the trial treatments
结局指标
主要结局
The rate of patients alive without progression 8 months after the inclusion.
The rate of patients alive without progression 8 months after the inclusion.
次要结局
- PFS will be defined as the time between date of inclusion and the date of the first radiological progression using RECIST v1.1 criteria and according to the investigator assessment or death
- DCR will be defined at each time-point as complete (CR), partial (PR), stability (S), progression (P) or not evaluable with imageries and according to the investigator
- ORR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria.
- BOR will be evaluated throughout the treatment by the imageries and according to RECIST v1.1 criteria
- DoR is defined as the time between the first response of the patient and the date of radiological progression or death
- TTP will be defined as the time between the date of inclusion and the date of the first radiological progression. The death linked to the cancer’s evolution will also be considered as an event
- OS is defined by the time between the date of inclusion and the date of death (regardless of the cause)
- Quality of life will be assessed with the EORTC QLQC30 questionnaire at each evaluation. The questionnaires are completed before the first treatment and during the study
- Geriatric assessments will be performed at baseline and during treatment using the G-CODE and G8-SCORE
- Toxicity, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be recorded until 30 days after the last administration of treatment
研究者
coordinator
Scientific
Fondation Franc.Cancerologie Digestive
研究点 (80)
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