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Recruiting Phase 1, Phase 2 NCT06379399

Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC

Trial Parameters

Condition Colorectal Cancer Metastatic
Sponsor Wangxia LV
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 26
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04
Completion 2025-03
Interventions
CetuximabTrifluridine/Tipiracil

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.

Eligibility Criteria

Inclusion Criteria: 1. Patient able and willing to provide written informed consent and to comply with the study protocol and follow-up inspection. 2. Histologically or cytologically confirmed metastatic adenocarcinoma of the colon; excluding appendiceal and anal canal cancers. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. 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). 6. Wild-type RAS/BRAF gene

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