Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592612
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Second-line Systemic Therapy Combined with SBRT for HCC with Oligoprogression After Standard First-line Systemic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Second-line Systemic Therapy with or Without Stereotactic Body Radiotherapy SBRT for Oligoprogressive Hepatocellular Carcinoma After Standard First-line Systemic Treatment a Prospective Randomized Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 26-31 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None