Hepatocellular CarcinomaNCT06708650
Combination of SFRT, PD-L1 Inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma
A study testing Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in people with Hepatocellular Carcinoma and Radiotherapy, run by Guiping People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Radiotherapy, PD-1 Inhibitors
- What is being tested?
- Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- Prior invasive malignancy unless disease-free for a minimum of 2 years
- 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
- Untreated active hepatitis B or hepatitis C
- Moderate to severe or intractable ascites
- Untreated or incompletely treated esophageal or gastric varices
Show all 12Show fewer
- 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
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior solid organ transplantation.
- Immunodeficiency diseases (including HIV) or autoimmune diseases require systemic immunosuppressive therapy (prednisone dosage>10mg per day)
- Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guiping People's Hospital
Guiping, Guangxi, 537200
Yaocan Xu, MD, 86+17376359808, gxmuxyc@163.com
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, PD-1 Inhibitors
- Being tested
- Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF
- Keywords
- Hepatocellular Carcinoma, radiotherapy, PD-1 Inhibitors, SFRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of SFRT, PD-L1 inhibitor, and Anti-VEGFRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma | Experimental | Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma Receives: Radiation: Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Objective response rate will be ratepresented as a proportion of the total.
Measured: 36 months after registration
Secondary outcomes (4)
Progression-free survival
Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
Measured: 36 months after registration
Overall survival
Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
Measured: 36 months after registration
Adverse event (Toxicity)
Toxicity will be evaluated using CTCAE version 5.0 and presented as a proportion of the total.
Measured: 36 months after registration
Tumor marker response: AFP
Tumor marker is descriptive as statistics such as mean, standard deviation, and median for continuous data will be presented, and changes in values before and after treatment will be compared and evaluated using paired t-test or Wilcoxon signed rank test.
Measured: 36 months after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiping People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaocan Xu, Youjiang Medical College for Nationalities
- Investigators
- Yaocan Xu, MD, Principal investigator, Guiping People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708650
- Sponsor's protocol ID
- GuipingPH-HCC-SFRT
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06708650
- Acronym / sponsor ID
- GuipingPH-HCC-SFRT
- Conditions
- Hepatocellular Carcinoma, Radiotherapy, PD-1 Inhibitors
- Keywords
- Hepatocellular Carcinoma, radiotherapy, PD-1 Inhibitors, SFRT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guiping People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma | Experimental | Radiation: Combination of SFRT, PD-L1 inhibitor, and Anti-VEGFCombination of SFRT, PD-L1 inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- Prior invasive malignancy unless disease-free for a minimum of 2 years
- 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
- Untreated active hepatitis B or hepatitis C
- Moderate to severe or intractable ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of SFRT, PD-L1 inhibitor, and Anti-VEGFPatients 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). | Radiation | Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in Advanced Hepatocellular Carcinoma |
Primary outcome
objective response rate (ORR)
Time frame: 36 months after registration
Objective response rate will be ratepresented as a proportion of the total.
4 secondary outcomes
Progression-free survival
Time frame: 36 months after registration
Overall survival
Time frame: 36 months after registration
Adverse event (Toxicity)
Time frame: 36 months after registration
Tumor marker response: AFP
Time frame: 36 months after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaocan Xu, MD principal investigator
Guiping People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of SFRT, PD-L1 inhibitor, and Anti-VEGF in people with Hepatocellular Carcinoma and Radiotherapy, run by Guiping People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaocan Xu, MD (86+17376359808, gxmuxyc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: 36 months after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.