NCT06708650Not yet recruiting
Combination of SFRT, PD-L1 Inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Nov 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Guiping People's Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06708650
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Jan 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
- Prior selective internal radiotherapy/ablation, at any time
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration Myocardial infarction within the last 6 months prior to study entry Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry A bleeding episode within 6 months prior to study entry due to any cause. Thrombolytic therapy within 28 days prior to study entry. Known bleeding or clotting disorder. Uncontrolled psychotic disorder
- Prior solid organ transplantation.
- Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
Other illness
- Prior invasive malignancy unless disease-free for a minimum of 2 years
- Untreated active hepatitis B or hepatitis C
- Immunodeficiency diseases (including HIV) or autoimmune diseases require systemic immunosuppressive therapy (prednisone dosage\>10mg per day)
Other
- Moderate to severe or intractable ascites
- Untreated or incompletely treated esophageal or gastric varices
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Who the study is looking for
- Age: 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-1 points；
- Patient clinically or pathologically diagnosed with hepatocellular carcinoma；
- Advanced hepatocellular carcinoma that is inoperable
- Expected survival period≥3 months;
- Liver function grade Child-Pugh A or better grade B (7 points);
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guiping People's Hospital Coordinator of this site? Confirm its status | Guiping | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.