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

NCT07683949 | Enrolling By Invitation Phase 1

• 1 other identifier: LENCAP-CRC
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Colorectal Cancer (Part 1)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Disease Control Rate

  baseline until disease progression or death from any cause, assessed up to 24 months

• Quality of Life Assessment

  QoL assessed at baseline and every 6 weeks during treatment, up to a maximum of 24 months.

• Overall Survival

  From the first dose of study treatment until death from any cause, assessed up to 48 months.

Study Arms (1)

Lenvanib (Lenvatinib)+Xeloda (capecitabine)

EXPERIMENTAL

Combination Product: Lenvanib (Lenvatinib),Xeloda (capecitabine)

Interventions

Lenvanib (Lenvatinib),Xeloda (capecitabine) COMBINATION_PRODUCT

* 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.

Lenvanib (Lenvatinib)+Xeloda (capecitabine)

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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.
• \) 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

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, 13605, South Korea

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: July 6, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

KR (1)