Metastatic Colorectal CancerNCT07263178
A Study of Second- and Later-line Palliative Chemotherapy in Patients With Metastatic Colorectal Cancer.
An observational study of Metastatic Colorectal Cancer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
This study aims to comprehensively identify the various treatment patterns of second- or subsequent-line palliative chemotherapy used in patients with metastatic colorectal cancer who have experienced failure of first-line palliative chemotherapy and to evaluate the prognosis of each treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Second and later-line palliative chemotherapy
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer (colon and rectal cancer) who have failed first-line palliative chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Seung Tae Kim, M.D., Ph.D.
About this study
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
This study aims to comprehensively identify the various treatment patterns of second- or subsequent-line palliative chemotherapy used in patients with metastatic colorectal cancer who have experienced failure of first-line palliative chemotherapy and to evaluate the prognosis of each treatment.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Second and later-line palliative chemotherapy
- Keywords
- Palliative chemotherapy, Metastatic Colorectal Cancer, Observation Study
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second and later-line palliative chemotherapyDrug
As this is a non-interventional study designed to collect data as part of routine clinical practice, the selection and dosage of medication, treatment period, and whether or not to change it are all based on the clinician's judgment
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) by treatment pattern
Measured: up to 24 months
Secondary outcomes (8)
Overall Survival (OS)
Overall Survival (OS) by treatment pattern
Measured: up to 24 months
Dosage period for each treatment pattern
Measured: up to 24 months
Objective Response Rate (ORR)
Measured: up to 24 months
Types of Secondary palliative chemotherapy
Measured: up to 24 months
Types of Third palliative chemotherapy
Measured: up to 24 months
Conversion rate
Conversion rate to resectable group by treatment pattern
Measured: up to 24 months
Quality of Life Assessment
The FACT-C (Functional Assessment of Cancer Therapy-Colorectal) questionnaire uses a 5-point Likert-type scale. The responses generally range from 0 (Not at all) to 4 (Very much).
Measured: up to 12 months
Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment
The ECOG PS uses a scale from 0 to 5, where a score of 5 specifically means the patient is deceased. The score of 0 indicates the best performance status (fully active), while 4 indicates the worst performance status for a living patient (completely disabled/bedridden).
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start7 Nov 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263178
- Sponsor's protocol ID
- BR-CPT-OS-402
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07263178
- Acronym / sponsor ID
- BR-CPT-OS-402
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Palliative chemotherapy, Metastatic Colorectal Cancer, Observation Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to comprehensively identify the various treatment patterns of second- or subsequent-line palliative chemotherapy used in patients with metastatic colorectal cancer who have experienced failure of first-line palliative chemotherapy and to evaluate the prognosis of each treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer (colon and rectal cancer) who have failed first-line palliative chemotherapy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second and later-line palliative chemotherapyAs this is a non-interventional study designed to collect data as part of routine clinical practice, the selection and dosage of medication, treatment period, and whether or not to change it are all based on the clinician's judgment | Drug | – |
Primary outcome
Progression-free survival (PFS)
Time frame: up to 24 months
Progression-free survival (PFS) by treatment pattern
8 secondary outcomes
Overall Survival (OS)
Time frame: up to 24 months
Dosage period for each treatment pattern
Time frame: up to 24 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Types of Secondary palliative chemotherapy
Time frame: up to 24 months
Types of Third palliative chemotherapy
Time frame: up to 24 months
Conversion rate
Time frame: up to 24 months
Quality of Life Assessment
Time frame: up to 12 months
Eastern Cooperative Oncology Group Performance Status(ECOG PS) Assessment
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shinyoung Oh (027088000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.