Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type Metastatic Colorectal Cancer: A Single-center, Prospective Phase Ib/II Study

Wangxia LV1 site in 1 country26 target enrollmentApril 2024

ConditionsColorectal Cancer Metastatic

InterventionsCetuximab Trifluridine/Tipiracil

DrugsCetuximab Trifluridine/Tipiracil

Overview

Phase: Phase 1
Intervention: Cetuximab
Conditions: Colorectal Cancer Metastatic
Sponsor: Wangxia LV
Enrollment: 26
Locations: 1
Primary Endpoint: Progression-free survival (PFS)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer.

Registry

clinicaltrials.gov

Start Date

April 2024

End Date

December 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wangxia LV

Responsible Party

Sponsor Investigator

Principal Investigator

Wangxia LV

Deputy Director of Colorectal Medicine

Zhejiang Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Patient able and willing to provide written informed consent and to comply with the study protocol and follow-up inspection.
•Histologically or cytologically confirmed metastatic adenocarcinoma of the colon; excluding appendiceal and anal canal cancers.
•Previously received at least second-line treatment, including two standard treatment regimens (such as fluoropyrimidine, capecitabine, irinotecan, oxaliplatin with or without anti-VEGF or anti-EGFR agents), if previously received first-line anti-EGFR therapy, achieving at least a partial response (PR) or above, with a discontinuation interval of at least one year.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) (based on RECIST 1.1 criteria, with the longest diameter of tumor lesions on CT/MRI scan ≥10mm, and the shortest diameter of lymph node lesions on CT/MRI scan ≥15mm).
•Wild-type RAS/BRAF gene detected.
•Able to take oral medication.
•Normal organ function, meeting the following criteria within 14 days before treatment initiation:
•Neutrophil count ≥1.5×10\^9/L;
•Platelet count ≥75×10\^9/L;

Exclusion Criteria

•Prior treatment with Trifluridine/Tipiracil;
•Patients with known dMMR or MSI-H advanced colorectal cancer who have not previously received anti-PD-1 or PD-L1 inhibitors;
•Participation in another drug clinical trial or receipt of systemic chemotherapy, radiotherapy, or biologic therapy within the past 4 weeks;
•Known or suspected brain metastases;
•Synchronous or metachronous cancer with a disease-free survival of ≥5 years (except for colorectal cancer) excluding cured or curatively treated mucosal cancers (esophageal cancer, gastric cancer, cervical cancer, non-melanoma skin cancer, bladder cancer, etc.);
•Factors significantly affecting oral drug absorption, such as dysphagia, chronic diarrhea, and gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
•Symptomatic malignant effusion requiring symptomatic treatment (including pleural effusion, ascites, pericardial effusion);
•Pregnant or lactating women; patients with reproductive potential unwilling or unable to use effective contraceptive measures;
•Known allergy to the investigational drug, drug class, or its components;
•Requirement for systemic corticosteroid therapy (excluding local steroids and cetuximab pre-treatment);

Arms & Interventions

Cetuximab Combined With Trifluridine/Tipiracil

Intervention: Cetuximab

Cetuximab Combined With Trifluridine/Tipiracil

Intervention: Trifluridine/Tipiracil

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: Approximately 12 months

Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

Secondary Outcomes

Disease Control Rate( DCR)(Approximately 12 months)
Adverse Events(safety)(Up to 28 days after discontinuation of study drug or start of subsequent therapy.)
Overall survival (OS)(Approximately 12 months)
Overall Response Rate (ORR)(Approximately 12 months)
Quality of life: EORTC QLQ-C30(Approximately 12 months)