EVALUATION OF BIODEGRADABLE NANOCARRIERS FOR TARGETED DRUG DELIVERY IN HEPATOCELLULAR CARCINOMA

Abstract

Objective:
This randomized controlled trial aimed to evaluate the efficacy and safety of biodegradable nanocarriers for targeted delivery of chemotherapeutic agents in patients diagnosed with hepatocellular carcinoma (HCC) at a tertiary hospital in Pakistan. The study compared nanoparticle-based drug delivery with conventional systemic chemotherapy in terms of treatment response, toxicity profile, pharmacokinetics, and overall patient survival.

Methods:
Patients with confirmed HCC were randomized into two groups: one receiving nanoparticle-based targeted chemotherapy and the other treated with conventional systemic chemotherapy. Treatment response was measured using RECIST criteria, while toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Pharmacokinetic and biodistribution studies were performed through blood sampling and imaging modalities. Survival analysis was conducted using Kaplan–Meier curves, and statistical significance was determined with log-rank tests.

Results:
The nanocarrier group demonstrated superior tumor targeting, with a significantly higher objective response rate (56.2% vs. 38.7%; p < 0.05). Patients in the experimental arm experienced fewer grade III–IV toxicities (21.4% vs. 42.3%), particularly reduced gastrointestinal and hematological side effects. Pharmacokinetic studies revealed enhanced drug accumulation in tumor tissue with lower systemic exposure. Median progression-free survival was improved in the nanocarrier group (11.6 months vs. 7.8 months), along with a modest but statistically significant increase in overall survival.

Conclusion:
Biodegradable nanocarriers offered a promising alternative to conventional systemic chemotherapy by improving tumor-targeted drug delivery, reducing systemic toxicity, and enhancing survival outcomes in patients with HCC. The trial highlighted the potential for integrating nanomedicine into routine oncology practice in Pakistan, while emphasizing the need for larger multicenter studies to validate these findings.