Recruiting

Lonsurf® with Chemotherapy for Metastatic Colorectal Cancer in Taiwan

Study Aim

This study focuses on determining how well Lonsurf combined with chemotherapy controls disease progression in patients with metastatic colorectal cancer in Taiwan.

What is being tested

Trifluridine/tipiracil

Drug

Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: March 2022

See protocol details

Summary

Principal SponsorChang Gung Memorial Hospital

Study ContactHung-Chih HsuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 19, 2022

Actual date on which the first participant was enrolled.

This study is investigating how effective Lonsurf® (Trifluridine/Tipiracil) combined with chemotherapy is for treating patients with metastatic colorectal cancer in Taiwan. Metastatic colorectal cancer is when the cancer has spread beyond the colon to other parts of the body. The research aims to determine if this treatment can improve the response rate in these patients, which means seeing a reduction in cancer size or spread. By exploring this combination therapy, the study seeks to find better treatment options for those who have limited responses to existing treatments. Participants in the study will receive Lonsurf® along with chemotherapy, and their response to the treatment will be closely monitored. The study uses a specific design that first enrolls 42 patients and evaluates their responses to decide whether to continue with more participants. If the initial results are promising, 28 more patients will be included, making a total of 70. Researchers will look for a certain number of positive responses to determine the effectiveness of the treatment. The study is structured to ensure reliable results and minimize the chance of error, providing a thorough assessment of the treatment's potential benefits.

Official TitleThe Efficacy of Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer: Multi-center Prospective Study in Taiwan

NCT06495463

Principal SponsorChang Gung Memorial Hospital

Study ContactHung-Chih HsuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

Criteria

7 inclusion criteria required to participate

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);

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6 exclusion criteria prevent from participating

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Chang-Gung Memorial Hospital, Linkou

Linkou District, TaiwanOpen Chang-Gung Memorial Hospital, Linkou in Google Maps

Recruiting

One Study Center