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

NCT06592612 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-10-31
Completion
2026-10-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592612 on ClinicalTrials.gov