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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT03869892
Eligibility Criteria:
Inclusion Criteria:
1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
2. RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
4. Patient is not a candidate for curative resection of metastatic lesions.
5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'
Exclusion Criteria:
8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
9. Participation in another interventional study within 4 weeks prior to the randomisation .
10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
11. Symptomatic central nervous system metastases.
12. Major surgery within 4 weeks prior to the randomisation.
Exclusion criteria related to S 95005 administration:
13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
14. Any contraindication present in the SmPC of trifluridine/tipiracil
Exclusion criteria related to bevacizumab administration:
15. Any contraindication present in the SmPC of bevacizumab
Exclusion criteria related to capecitabine administration:
16. Any contraindication present in the SmPC of capecitabine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03869892
Study Brief:
Protocol Section:
NCT03869892