NCT06592612

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

Not yet recruiting Phase 2 Last updated 19 September 2024

What this trial tests

Phase 2 trial testing SBRT and second-line systemic therapy in Hepatocellular Carcinoma in 70 participants. Not yet recruiting.

Timeline

1 October 2024

Primary endpoint
31 October 2026

31 October 2026

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	1 October 2024
Primary completion	31 October 2026
Estimated completion	31 October 2026

Drugs / interventions tested

• SBRT and second-line systemic therapy
• Second-line systemic therapy — full drug profile →

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
• Oligoprogression — all drugs for Oligoprogression →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma or Oligoprogression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Approximately 70% of hepatocellular carcinoma (HCC) patients are diagnosed at an advanced stage, with no opportunity for curative treatments. For these patients, systemic therapies are the main treatment modalities. However, the objective response rates of first-line systemic treatments are currently only 20-35%, and most patients inevitably develop drug resistance and disease progression during treatment, thus taking second-line therapies. Second-line treatment options include regorafenib, pembrolizumab, and others, but clinical studies have shown a median progression-free survival of only 2.6-3.1 months, indicating an urgent need to improve efficacy.

Stereotactic body radiotherapy (SBRT) has been widely used in recent years for curative treatment of early-stage liver cancer or as neoadjuvant and adjuvant therapy for patients with portal vein tumor thrombus. It is one of the important approaches in the multidisciplinary management of HCC. Researches have shown that SBRT has a synergistic effect with systemic drug therapy, potentially enhancing the efficacy of targeted and immunotherapies. Therefore, this study aims to conduct a prospective, randomized, controlled phase II clinical trial in patients with oligoprogressive HCC after standard first-line systemic treatment to evaluate whether adding SBRT to second-line systemic therapy can improve the efficacy of second-line treatment. The primary endpoint of the study is progression-free survival (PFS), while secondary endpoints include overall survival (OS), objective response rate (ORR), and treatment-related adverse events. We aim to comprehensively assess the effectiveness and safety of combining SBRT with second-line systemic therapy in treating oligoprogressive HCC patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Combining External Beam Radiotherapy and Immunotherapy for the Treatment of Hepatocellular Carcinoma.
   Le C, Abraham AG, Tankel K, Usmani N, et al · · 2026 · PMID 42041745 · DOI 10.3390/curroncol33040226