RecruitingNot ApplicableNCT06495463

Lonsurf® (Trifluridine/Tipiracil) Plus Chemotherapy in Metastatic Colorectal Cancer Prospective Study in Taiwan

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

110 participants

Start Date

Mar 19, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

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

Eligibility

Inclusion Criteria7

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.

Exclusion Criteria6

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.

Interventions

DRUGTrifluridine/tipiracil

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.