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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chang-Gung Memorial Hospital, Linkou
RECRUITING
Linkou District
Contact Information
Primary
Hung-Chih Hsu
dannyhsuyoyo@gmail.com
+886 33281200
Backup
Ya-Wen Ho
vengi0512@tty.com.tw
+886 975872851
Time Frame
Start Date: 2022-03-19
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 110
Treatments
Experimental: trifluridine / tipiracil + Chemotherapy
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.
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov