Ireland
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Enrolling by invitation Phase 1/2

Clinical Trial Evaluating the Efficacy of Capecitabine Plus Lenvatinib in Patients With Advanced Colorectal Cancer Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidine

NCT07683949 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2026-06-15
Last updated
2026-07-06

Condition(s) studied

Advanced Colorectal Cancer (Part 1)

Investigational drug(s) / intervention(s)

Lenvanib (Lenvatinib),Xeloda (capecitabine)

Lenvanib (Lenvatinib),Xeloda (capecitabine): * Phase I: Lenvatinib dose will be determined using a standard 3+3 dose-escalation design (see table below). * Phase II: Capecitabine 1,000 mg/m² twice daily (BID; administered for 2 weeks followed by 1 week off) in combination with lenvatinib at the dose determined in Phase I, administered once daily (QD), in 3-week cycles.

Study summary

A New Treatment Opportunity for Patients with Advanced Colorectal Cancer Refractory to Standard Chemotherapy: Clinical Trial of Capecitabine plus Lenvatinib Combination Therapy

Eligibility

Sex
ALL
Min age
19 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 1\) Voluntarily signed written informed consent 2) Male or female ≥19 years of age 3) Histologically confirmed metastatic or unresectable colorectal adenocarcinoma 4) Metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines 5) ECOG performance status 0, 1, or 2 6) Measurable lesion per RECIST v1.1 7) Hemoglobin ≥9.0 g/dL, ANC ≥1,500/μL, Platelets ≥100,000/μL, Serum creatinine \<1.5×ULN, AST/ALT \<3×ULN, Total bilirubin \<1.5×ULN (all without transfusion or G-CSF within 14 days of screening) 8) Able to understand and comply with the study protocol through completion 9) Women of childbearing potential: negative pregnancy test within 14 days before first dose; agreement to use adequate contraception for ≥6 months after last dose 10) Men with pregnant or potentially pregnant partners: agreement to use adequate contraception (e.g., condom) for ≥3 months after last dose Exclusion Criteria: * 1\) Pregnant or breastfeeding women 2) History of another malignancy within the past 5 years (except papillary or follicular thyroid cancer) 3) Uncontrolled infection or other systemic diseases 4) Known hypersensitivity to the investigational drugs 5) Presence of bowel stent or biliary stent with risk of perforation or bleeding 6) Esophageal/gastric varices or other risk of gastrointestinal hemorrhage 7) Presence of significant uncontrolled concurrent illness or recent medical condition, including but not limited to: * Significant cardiovascular disorder: congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction, or cerebrovascular accident within 6 months prior to the first dose; or history of cardiac arrhythmia requiring treatment at screening. * Uncontrolled hypertension (systolic BP \>150 mmHg or diastolic BP \>90 mmHg) despite optimized antihypertensive therapy. * Thromboembolic disorder or significant risk of severe hemorrhage. The degree of tumor invasion of major blood vessels (e.g., carotid artery) must be considered due to the potential risk of serious hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy. 8\) Uncontrolled proteinuria (3+ or higher on spot urinalysis; 2+ acceptable only if U/PCR ≤1 g/Cr) 9) QTcF \>480 msec 10) Known DPD (dihydropyrimidine dehydrogenase) deficiency 11) Active CNS metastases and/or carcinomatous meningitis 12) Judged ineligible by the investigator 13) Major surgery within 1 month prior to enrollment 14) Receipt of another investigational drug within 4 weeks prior to enrollment or currently enrolled in another clinical trial 15) Requiring concurrent systemic anticancer therapy during the study 16) Currently receiving prohibited concomitant medications (e.g., sorivudine and analogues, allopurinol) that cannot be discontinued before first dose

Primary outcome measure(s)

  • Primary Efficacy Analysis — rom the first dose of study treatment until documented disease progression, treatment discontinuation, withdrawal of consent, death, or end of study, with tumor response assessed every 6 weeks, up to 48 months.
    Outcome Measure Title: Objective Response Rate (ORR) per RECIST v1.1 Outcome Measure Description: Objective Response Rate (ORR) is defined as the proportion of treated patients who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to RECIST v1.1. Tumor response will be evaluated using CT or MRI every 6 weeks. The best overall response will be determined from the start of study treatment until disease progression, treatment discontinuation, death, or end of study. ORR will be summarized with a 95% confidence interval.

Trial sites (1)

FacilityCityRegionStatus
172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea Seoul National University Bundang Hospital, Health Care Innovation Park 5Fr. D5-01 Seongnam-si Out of US
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07683949 on ClinicalTrials.gov ↗ ← All trials in South Korea