Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-05 @ 12:34 PM
Study NCT ID:
NCT06708650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of SFRT, PD-L1 Inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma
Sponsor:
Guiping People's Hospital
Organization:
Study Overview
Official Title:
A Single-arm, Single-center, Open-label Study to Evaluate the Efficacy and Safety of SFRT Combined With PD-1 Inhibitors and Anti-VEGFR in Unresectable Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PD-1 inhibitor plus anti-VEGFR has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of around 30%, the majority of patients face HCC progression and liver failure. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes. Stereotactic radiotherapy (SBRT) can enhance immune response through various mechanisms, and its immunomodulatory effect has been confirmed in multiple solid tumors. However, due to the limitation of the OAR tolerance dose, large-volume tumors are unsuitable for SBRT treatment. To overcome this issue, researchers have introduced the spatially fractionated radiation therapy (SFRT) mode, which allows for a highly uneven radiation dose distribution within the tumor volume. SFRT is an emerging radiotherapy technique with high clinical response rates and low radiation-related toxicity in large-volume solid tumors. Therefore, the investigators conducted this single-arm, single-arm, open-label study to evaluate the efficacy and safety of SFRT combined with PD-1 inhibitors and anti-VEGFR in unresectable HCC. The primary endpoint is objective response rate (ORR), and secondary endpoints include overall survival (OS), progression-free survival (PFS), and toxicity.
Detailed Description:
This is a single-arm, single-center, open-label study to evaluate the efficacy and safety of SFRT combined with PD-1 inhibitors (Camrelizumab, Tislelizumab or Sintilimab) and anti-VEGFR (Apatinib or Lenvatinib) in unresectable HCC. Patients received intravenous PD-1 inhibitor 200mg(Camrelizumab, Tislelizumab, or Sintilimab) plus oral Apatinib 250 mg or Lenvatinib 12mg (for bodyweight ≥60 kg) or 8 mg/kg (for bodyweight \<60 kg) daily, and additional SFRT for primary liver tumor. PD-1 inhibitor is administered for 2 years or until disease progression or intolerance. Anti-VEGFR is continued until disease progression or intolerance. SFRT implementation plan is as follows: The GTV consists of 2-5 sub-target volumes, which are cylindrical shapes with a diameter of 1.6cm, a height of 2cm, and an interval of 3-5cm. The total volume of the GTV is about 8-20cc, and the distance between the GTV and the OARs is greater than 2cm. The prescribed dosage for each course of radiotherapy is 24 Gy in 3 daily fractions (8Gy x 3F), with a 3-week interval between courses (Q3W). The total courses of radiotherapy shall not be less than 2 (depending on the efficacy and cumulative dose of OARs). The primary endpoint is objective response rate (ORR), and secondary endpoints include overall survival (OS), progression-free survival (PFS), and toxicity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: