Second- and later-line palliative chemotherapy options for metastatic colorectal cancer.
Official title: A Multi-center, Prospective, Observational Study to Assess the Treatment Patterns and Prognosis of Second and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer Who Failed First-line Palliative Chemotherapy
Run by Boryung Pharmaceutical Co., Ltd · NCT07263178 · Data updated 2026-11-12
This study will see how different second- or later-line palliative chemotherapy treatments are used and what outcomes patients with metastatic colorectal cancer have after first-line chemotherapy stops working.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07263178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with measurable metastatic colorectal cancer who have failed first-line palliative chemotherapy and are about to begin their first second-line palliative chemotherapy and who can provide informed consent are ideal candidates.
✕Probably not a fit
Patients looking for experimental investigational treatments, those who are pregnant or breastfeeding, or those unable to attend visits at the Seoul study site are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling patients with histologically and radiologically confirmed metastatic colorectal cancer who are starting their first second-line palliative chemotherapy after failure of first-line treatment. Investigators will record the specific chemotherapy regimens, dosing, timing, and any supportive treatments, and will track tumor responses, progression, survival, and adverse events over time. The goal is to describe real-world treatment patterns and compare prognosis across the commonly used second- and later-line regimens. The study is conducted at Samsung Medical Center and sponsored by Boryung Pharmaceutical Co., Ltd.
Why it matters
Potential benefit: If successful, results could help doctors choose second-line palliative chemotherapy regimens that are associated with better outcomes and set clearer expectations for patients.
How similar studies have gone: Similar observational analyses of real-world treatment patterns in metastatic colorectal cancer have been performed and have informed clinical practice, so this approach is established rather than novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have signed the informed consent after receiving information about the purpose and method of this study. * Patients with histologically and radiologically confirmed metastatic colorectal cancer (colorectal cancer) who have evaluable (measurable) lesions. * Patients scheduled to receive their first second-line palliative chemotherapy following failure of first-line palliative chemotherapy (including those who relapse during or within 6 months after completion of postoperative adjuvant therapy, necessitating palliative chemotherapy). * Patients who understand the research, are cooperative in the research process, and are deemed capable of participating until the completion date. Exclusion Criteria: * Female patients who are pregnant, have childbearing potential, or are breastfeeding. * Has received an investigational product within 4 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study. * Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.
Where it's running
-
Samsung Medical Center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: 027088000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer
This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.
-
DEM301 in advanced colorectal cancer: a first-in-human test
This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.
-
Immunotherapy plus Simvastatin and Targeted Therapy with Chemotherapy for Advanced Colorectal Cancer
This trial tests whether adding immune therapy (adbelimumab? actually Adebrelimab) with simvastatin and targeted therapy to standard chemotherapy helps people with metastatic colorectal cancer that is MSI-H/dMMR or MSS/pMMR depending on combination.
-
Fruquintinib treatment in adults with metastatic colorectal cancer in Poland
This study looks at whether taking fruquintinib by mouth after prior therapies helps adults with metastatic colorectal cancer in Poland live longer before the cancer progresses and overall survival, while also considering quality of life.
-
Understanding why BRAF V600E colorectal cancer stops responding to targeted therapy
This study tests why metastatic colorectal cancer with a BRAF V600E mutation stops responding to encorafenib and cetuximab, by collecting tissue, blood, and stool samples over time.
-
Second-line combination treatment for MSS metastatic colorectal cancer
This trial will try folinic acid plus continuous 5-FU with liposomal irinotecan, sometimes combined with cetuximab or bevacizumab, as a second-line option for adults with MSS metastatic colorectal cancer who progressed on or cannot tolerate oxaliplatin-based therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.