A New Treatment Opportunity for Patients with Advanced Colorectal Cancer Refractory to Standard Chemotherapy: Clinical Trial of Capecitabine plus Lenvatinib Combination Therapy
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
* 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.
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, South Korea
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.
Time frame: 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.
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.
Time frame: 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.
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Time frame: 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.
Time frame: From the first dose of study treatment until death from any cause, assessed up to 48 months.