A Phase 2 Trial of Spatially Fractionated Radiotherapy for Large Hepatocellular Carcinoma (LATTICE-HCC)

Hepatocellular carcinoma is a common liver cancer and many patients present with large unresectable tumors that are not suitable for surgery transplantation or other local therapies. Radiotherapy has become an important treatment option but dose escalation is limited because of the risk of liver toxicity and damage to surrounding organs.

Spatially fractionated radiotherapy using a lattice technique is a modern radiotherapy approach that delivers higher radiation doses to selected regions within the tumor while maintaining a lower dose to the surrounding tissue. This method may improve tumor response while reducing toxicity to normal liver tissue.

This prospective single arm phase two study will evaluate the safety feasibility and clinical outcomes of spatially fractionated radiotherapy in patients with large unresectable hepatocellular carcinoma. A total of twenty patients fulfilling the eligibility criteria will be treated using volumetric modulated arc therapy based lattice radiotherapy.

The primary objective is to assess local tumor control at six months after treatment. Secondary objectives include evaluation of progression free survival overall survival treatment related toxicity changes in liver function and quality of life. Patients will be followed with clinical examination laboratory tests and imaging studies during and after treatment.

The results of this study may help determine the role of spatially fractionated radiotherapy as a treatment option for patients with large hepatocellular carcinoma in the Indian clinical setting.