Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT05468892
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven diagnosis of colorectal adenocarcinoma
* Diagnosis of metastatic disease
* RAS (NRAS and KRAS exon 2,3 and 4) wild-type in tissue at initial diagnosis
* Efficacy of a first line therapy containing an anti-EGFR agent (panitumumab or ceuximab) with a major response achieved (complete or partial response)
* Progression after a second line therapy
* Available and adequate baseline tumour tissue sample
* Measurable disease according to RECIST criteria v1.1
* Male or female patients \> 18 years of age
* ECOG Performance Status 0-1
* Life expectancy of at least 3 months
* Adequate bone marrow, liver and renal function
* If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 14 days before initiation of study treatment
* If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method)
* Signed informed consent
Exclusion Criteria:
* Any contraindication to use Trifluridine - Tipiracil or Panitumumab
* More than two previous lines of treatment
* Active uncontrolled infections
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Pregnancy
* Breastfeeding
* Interstitial lung disease or pulmonary fibrosis
* Grade III or IV heart failure (NYHA classification)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05468892
Study Brief:
Protocol Section:
NCT05468892