Metastatic Colorectal CancerNCT06495463
Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan
A study testing Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Primary Endpoint : To evaluate the Disease control rate (DCR) Secondary Endpoints: To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Trifluridine/tipiracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer;
- Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy;
- The RAS wild-type patients need to receive anti-EGFR therapy;
- Presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by CT scan, MRI and PET-CT(no less than double the slice thickness and a minimum of 10mm)(according to RECIST guideline version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
- Investigators prescribe Lonsurf® for metastatic colorectal cancer patients who had prior treatment with Anti-VEGF and Anti-EGFR agent on routine basis. Depending on RAS status, patients with RAS mutant receive Lonsurf® as 3rd line treatment, those with RAS wild type receive Lonsurf® as 3rd/4th line treatment;
- Patients received either oxaliplatin or irinotecan.
Who cannot join
- Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib;
- With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth);
- With clinically significant gastrointestinal hemorrhage;
- Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
- The patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance;
- Active infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan
Primary Endpoint : To evaluate the Disease control rate (DCR)
Secondary Endpoints:
To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile
Read the detailed description
70 Per-protocol patients Plan to recruit 70 evaluable patients (With expected dropout rate of 22%, the sample size would be 90 subjects.) Simon's two-stage design (Simon, 1989) will be used. The null hypothesis that the true response rate is 0.45 will be tested against a one-sided alternative. In the first stage, 42 patients will be accrued. If there are 19 or fewer responses in these 42 patients, the study will be stopped. Otherwise, 28 additional patients will be accrued for a total of 70. The null hypothesis will be rejected if 39 or more responses are observed in 70 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true response rate is 0.6.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Trifluridine/tipiracil
- Keywords
- trifluridine/tipiracil, combination chemotherapy, metastatic colorectal cancer, irinotecan, oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/tipiracilDrug
Also called (choose one combination) : oxalipatin or irinotecan
Trifluridine/tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off
(choose one combination) : oxalipatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days.
| Study group | Role | What they receive |
|---|---|---|
| trifluridine / tipiracil + Chemotherapy | Experimental | trifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off
combination with chemotherapy (choose one) : oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days. Receives: Drug: Trifluridine/tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
The endpoints Disease Control Rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response (CR), partial response (PR) or stable disease (SD).
Measured: Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.
Secondary outcomes (3)
Progression-free survival (PFS)
Progression-free survival (PFS) refers to the first treatment of trifluridine/tipiracil to disease progression or death.
Measured: The evaluation period is up to 24 months from the date of ICF is signed to the date of first recorded progress.
Overall survival(OS)
Overall survival (OS) is defined from the first treatment of Lonsurf® to death.
Measured: The evaluation period is up to 48 months from the date of ICF is signed to the date of death.
Safety profile
All adverse events (AEs) will be summarized and listed. All adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected, and graded according to the common terminology criteria for adverse events (CTCAE) version 5.00.
Measured: The evaluation period is up to 24 months from all adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start19 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- trifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off Chemotherapy (choose one) : oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Chih Hsu, Principal investigator, Chang Gung Memorial Hospital, Linkou, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495463
- Sponsor's protocol ID
- 202200069A3
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
PubMed 25970050Temmink OH, Hoebe EK, van der Born K, Ackland SP, Fukushima M, Peters GJ. Mechanism of trifluorothymidine potentiation of oxaliplatin-induced cytotoxicity to colorectal cancer cells. Br J Cancer. 2007 Jan 29;96(2):231-40. doi: 10.1038/sj.bjc.6603549.
PubMed 17242697Temmink OH, Hoebe EK, Fukushima M, Peters GJ. Irinotecan-induced cytotoxicity to colon cancer cells in vitro is stimulated by pre-incubation with trifluorothymidine. Eur J Cancer. 2007 Jan;43(1):175-83. doi: 10.1016/j.ejca.2006.08.022. Epub 2006 Oct 16.
PubMed 17049227Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.
PubMed 30889492Doi T, Yoshino T, Fuse N, Boku N, Yamazaki K, Koizumi W, Shimada K, Takinishi Y, Ohtsu A. Phase I study of TAS-102 and irinotecan combination therapy in Japanese patients with advanced colorectal cancer. Invest New Drugs. 2015 Oct;33(5):1068-77. doi: 10.1007/s10637-015-0271-1. Epub 2015 Jul 12.
PubMed 26163340Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan
- ClinicalTrials.gov ID
- NCT06495463
- Acronym / sponsor ID
- 202200069A3
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- trifluridine/tipiracil, combination chemotherapy, metastatic colorectal cancer, irinotecan, oxaliplatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 19 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jul 2024 (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.
Primary Endpoint : To evaluate the Disease control rate (DCR)
Secondary Endpoints:
To evaluate the Progression-free survival (PFS), Overall survival(OS) and Safety profile
Detailed description
70 Per-protocol patients Plan to recruit 70 evaluable patients (With expected dropout rate of 22%, the sample size would be 90 subjects.) Simon's two-stage design (Simon, 1989) will be used. The null hypothesis that the true response rate is 0.45 will be tested against a one-sided alternative. In the first stage, 42 patients will be accrued. If there are 19 or fewer responses in these 42 patients, the study will be stopped. Otherwise, 28 additional patients will be accrued for a total of 70. The null hypothesis will be rejected if 39 or more responses are observed in 70 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true response rate is 0.6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- trifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off Chemotherapy (choose one) : oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days.
| Arm | Type | Receives |
|---|---|---|
| trifluridine / tipiracil + Chemotherapy | Experimental | Drug: Trifluridine/tipiraciltrifluridine / tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off combination with chemotherapy (choose one) : oxaliplatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed adenocarcinoma of the metastatic colorectal cancer;
- Previously treated with fluorouracil-, oxaliplatin-, and irinotecan-based chemotherapy, and anti-vascular endothelial growth factor (anti-VEGF) biological therapy;
- The RAS wild-type patients need to receive anti-EGFR therapy;
- Presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of : 10mm by CT scan, MRI and PET-CT(no less than double the slice thickness and a minimum of 10mm)(according to RECIST guideline version 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2;
Key exclusion criteria (6 listed)
- Patients previously received Lonsurf® (Trifluridine／Tipiracil) or regorafenib;
- With active central nervous system (CNS) metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth);
- With clinically significant gastrointestinal hemorrhage;
- Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
- The patient at high risk from treatment complications including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, uncontrolled diabetes, liver or renal failure and psychiatric illness or social situation that would preclude study compliance;
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 |
|---|---|---|
| Trifluridine/tipiracilAlso: (choose one combination) : oxalipatin or irinotecanTrifluridine/tipiracil 35 mg/m2 PO twice daily on days 1-5 and day 6-14 off (choose one combination) : oxalipatin 85mg/m2 IV on day 1 every 14 days or irinotecan 100mg/m2 IV on day 1 every 14 days. | Drug | trifluridine / tipiracil + Chemotherapy |
Primary outcome
Disease control rate (DCR)
Time frame: Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.
The endpoints Disease Control Rate (DCR) is defined as the proportion of patients in whom the best overall response is determined as complete response (CR), partial response (PR) or stable disease (SD).
3 secondary outcomes
Progression-free survival (PFS)
Time frame: The evaluation period is up to 24 months from the date of ICF is signed to the date of first recorded progress.
Overall survival(OS)
Time frame: The evaluation period is up to 48 months from the date of ICF is signed to the date of death.
Safety profile
Time frame: The evaluation period is up to 24 months from all adverse events occurring between the first drug intake and 30 days (inclusive) after the last administration of trial medication will be collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 25970050Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.
- Background: PubMed 17242697Temmink OH, Hoebe EK, van der Born K, Ackland SP, Fukushima M, Peters GJ. Mechanism of trifluorothymidine potentiation of oxaliplatin-induced cytotoxicity to colorectal cancer cells. Br J Cancer. 2007 Jan 29;96(2):231-40. doi: 10.1038/sj.bjc.6603549.
- Background: PubMed 17049227Temmink OH, Hoebe EK, Fukushima M, Peters GJ. Irinotecan-induced cytotoxicity to colon cancer cells in vitro is stimulated by pre-incubation with trifluorothymidine. Eur J Cancer. 2007 Jan;43(1):175-83. doi: 10.1016/j.ejca.2006.08.022. Epub 2006 Oct 16.
- Background: PubMed 30889492Argiles G, Andre T, Hollebecque A, Calvo A, Dahan L, Cervantes A, Leger C, Amellal N, Fougeray R, Tabernero J. Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer. Eur J Cancer. 2019 May;112:12-19. doi: 10.1016/j.ejca.2019.01.101. Epub 2019 Mar 16.
- Background: PubMed 26163340Doi T, Yoshino T, Fuse N, Boku N, Yamazaki K, Koizumi W, Shimada K, Takinishi Y, Ohtsu A. Phase I study of TAS-102 and irinotecan combination therapy in Japanese patients with advanced colorectal cancer. Invest New Drugs. 2015 Oct;33(5):1068-77. doi: 10.1007/s10637-015-0271-1. Epub 2015 Jul 12.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Ministry of Health and Welfare, National Health Service. Cancer Registration ReportLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Hung-Chih Hsu principal investigator
Chang Gung Memorial Hospital, Linkou, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2026. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) (time frame: Tumor response will be judged according to RECIST v 1.1 criteria within every 8 weeks(± 2 week) in treatment period. The evaluation period is up to 24 months from the date of ICF is signed to first recorded progress or death whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06495463, which also lists 6 linked publications.
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 2 Sep 2026.