Second-line Systemic Therapy Combined with SBRT for HCC with Oligoprogression After Standard First-line Systemic Treatment

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Hepatocellular CarcinomaOligoprogression
Interventions
RADIATION

SBRT and second-line systemic therapy

Patients in the SBRT arm will receive second-line systemic therapy combined with SBRT. The choice and stipulations for second-line systemic therapy drugs are the same as those for the control arm.SBRT will be administered to all oligoprogressive lesions and must begin within 2 weeks after the start of second-line therapy. Systemic therapy will not be paused during SBRT. Patients who do not withdraw from the study will not receive crossover treatment; however, if a patient in the control group withdraws from the study due to tumor progression and is assessed as suitable for SBRT, salvage SBRT will be administered promptly.

DRUG

Second-line systemic therapy

Patients in the control arm will receive second-line systemic therapy. The following stipulations apply to the second-line treatment drugs: for patients who received bevacizumab combined with atezolizumab/sintilimab as the first-line treatment, lenvatinib or regorafenib will be used for second-line treatment; for patients who received lenvatinib with or without PD-1 antibody as the first-line treatment, regorafenib combined with another PD-1 antibody will be used for second-line treatment.

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT06592612 - Second-line Systemic Therapy Combined with SBRT for HCC with Oligoprogression After Standard First-line Systemic Treatment | Biotech Hunter | Biotech Hunter