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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced Colorectal Cancer (Part 1)
• Intervention / Treatment: Combination product: Lenvanib (Lenvatinib),Xeloda (capecitabine)

Detailed Description

This study is for patients with "refractory advanced colorectal cancer" whose tumor has progressed or did not respond to standard, widely used chemotherapies (irinotecan, oxaliplatin, and fluoropyrimidine-based drugs). The purpose of this study is to evaluate the effectiveness and safety of combining Capecitabine (an oral chemotherapy drug) with Lenvatinib (a targeted therapy that blocks blood vessels that help tumors grow)

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Out of US
    • Seongnam-si, Out of US, South Korea, 13605
      • 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea Seoul National University Bundang Hospital, Health Care Innovation Park 5Fr. D5-01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenvanib (Lenvatinib)+Xeloda (capecitabine)	Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Analysis	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate	The proportion of all patients achieving complete response , partial response , or stable disease will be calculated and presented with a 95% confidence interval.	baseline until disease progression or death from any cause, assessed up to 24 months
Quality of Life Assessment	QoL will be assessed using the FACT-G7 questionnaire. To compare score changes between baseline and post-treatment time points: If data satisfy normality: paired t-test will be used.; If data do not satisfy normality: Wilcoxon signed-rank test will be used. QoL changes will be presented as descriptive statistics showing the score change from baseline at each time point. A Linear Mixed Model (LMM) or Repeated Measures ANOVA will be used to statistically test the trend of score changes over time. Item-level missing data Prorating per the FACT-G7 Scoring will be applied. In general, if ≥50% of items comprising a subscale are answered, the missing items will be imputed by the mean score of the answered items. Visit-level missing data Primary analysis will be based on patients with available data at both baseline and the assessment time point. To characterize the pattern and cause of missing data, the questionnaire compliance rate at each time point will be reported as statistics.	QoL assessed at baseline and every 6 weeks during treatment, up to a maximum of 24 months.
Overall Survival	Overall Survival (OS) is defined as the time from the first dose of study treatment to death from any cause. OS will be analyzed using the Kaplan-Meier method and reported in months.	From the first dose of study treatment until death from any cause, assessed up to 48 months.

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine
• Other Study ID Numbers: LENCAP-CRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) may be made available to researchers requesting it for scientific purposes after the completion of the study, subject to approval by the principal investigator and review by the relevant institutions.
• IPD Sharing Time Frame: De-identified individual participant data (IPD) and related information will be available starting six months after study completion, and access may be granted for up to five years from the date of request.
• IPD Sharing Access Criteria: Access to IPD and related information will be granted only to qualified researchers conducting studies for scientific purposes. The shared data will include de-identified participant information, clinical assessment results, treatment information, and safety data, excluding directly identifiable information such as names or national ID numbers. Access will be provided following approval by the principal investigator and review by the relevant institutions, through a secure data-sharing platform or encrypted files.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No