Hepatocellular CarcinomaPhase 2NCT07274774
SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
A Phase 2 study testing Systemic therapy and Radiotherapy in people with Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma
- What is being tested?
- Systemic therapy and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 10 Nov 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years.
- Histologically or clinically diagnosed HCC per national guidelines.
- BCLC stage C (CNLC IIIA/IIIB), including PVTT and/or extrahepatic metastases amenable to protocol procedures.
- Child-Pugh class A or B (score ≤7).
- At least one measurable lesion per RECIST 1.1 (criteria specified).
- ECOG ≤2.
Show all 12Show fewer
- Expected survival ≥6 months.
- Adequate organ function per protocol thresholds.
- For experimental arm candidates: active lesion count (when PET-CT used) ≤10.
- If prior initial systemic therapy given: intrahepatic disease stable ≥3 months.
- Effective contraception from consent through 1 year after treatment end.
- Ability to understand and sign consent.
Who cannot join
- Second primary malignancy (exceptions apply).
- Tumor thrombus/metastases judged not amenable to radiotherapy.
- Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).
- Severe organ dysfunction precluding treatment.
- Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
- Active uncontrolled infection or active autoimmune disease requiring systemic therapy.
Show all 10Show fewer
- Significant neurologic dysfunction.
- Pregnant or breastfeeding women; no effective contraception.
- Known hypersensitivity to planned drugs.
- Any other condition making participation unsuitable per investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Therapy Combined With Stereotactic Body Radiotherapy Versus Systemic Therapy Alone in BCLC Stage C Hepatocellular Carcinoma (SCRATCH): A Prospective, Multicenter, Phase II, Randomized Controlled Trial
This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Secondary objectives include progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and incidence and severity of adverse events (AEs). Eligible patients will be randomized 2:1 to an experimental arm (SBRT + systemic therapy) or control arm (systemic therapy alone). Key inclusion criteria include BCLC C disease, Child-Pugh A-B liver function, ECOG ≤2, measurable disease per RECIST 1.1, and stable intrahepatic disease after initial systemic therapy for ≥3 months when applicable. The trial will also include predefined safety monitoring, QoL assessments (EORTC QLQ-C30 and QLQ-HCC18), and exploratory biomarker analyses.
Read the detailed description
Background: Hepatocellular carcinoma (HCC) is frequently diagnosed at advanced stages with limited curative options. Systemic therapies (targeted agents and immune checkpoint inhibitors) have improved outcomes in BCLC C patients, but their therapeutic effect is unsatisfactory. SBRT provides precise high-dose local control and may synergize with systemic therapy by enhancing tumor immunogenicity and improving local disease control.
Study design: Prospective, randomized, open-label, multicenter Phase II trial. In the experimental arm, patients will continue the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines, combined with SBRT delivered to portal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic metastatic lesions. In the control arm, patients will continue the same guideline-recommended systemic treatment without SBRT.
Endpoints: The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR by RECIST 1.1 and mRECIST), disease control rate (DCR), duration of response (DoR), quality of life (EORTC QLQ-C30 and QLQ-HCC18), and safety (CTCAE v5.0). Exploratory endpoints may include biomarker dynamics (e.g., immune cell infiltration, viral markers) and patterns of progression.
Safety and monitoring: AEs will be collected from consent through 30 days after the last radiotherapy; SAEs will be reported per protocol (including deaths up to 90 days after radiotherapy). Regular imaging and clinical assessments will monitor efficacy and safety. Data management and monitoring will follow GCP.
- Being tested
- Systemic therapy, Radiotherapy
- Keywords
- hepatocellular carcinoma, BCLC stage C, metastasis, radiotheraphy
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic therapyDrug
Systemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines
RadiotherapyRadiation
portal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic active lesions. For patients presenting with more than 10 lesions at baseline (including extrahepatic metastases with or without portal vein tumor thrombus), a comprehensive FDG-PET/CT reassessment of the whole body is required after 3 months of systemic therapy. Patients who demonstrate ≤10 active lesions at this reassessment may then be considered eligible for SBRT. Dose and fractionation: total dose 25-40 Gy delivered in 5 fractions (5-8 Gy per fraction). Dose selection individualized based on tumor size, location and nearby organ-at-risk constraints; sequential or staged SBRT allowed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | SBRT + Systemic Therapy Receives: Drug: Systemic therapy; Radiation: Radiotherapy |
| Control | Other | Systemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines. Receives: Drug: Systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from date of randomization to date of death from any cause
Measured: subjects will be followed up for a minimum combined accrual + follow-up period of 48 months (24-month enrollment + 24-month follow-up planned)
Secondary outcomes (7)
Progression-Free Survival (PFS)
Time from randomization to radiographic disease progression per RECIST 1.1/mRECIST or death
Measured: 2 years
Objective Response Rate (ORR)
proportion achieving CR or PR by RECIST 1.1 and mRECIST; assessed at scheduled imaging
Measured: 2 years
Disease Control Rate (DCR)
proportion achieving CR + PR + SD
Measured: 2 years
Duration of Response (DoR)
from first documented CR/PR to progression or death
Measured: 2 years
Quality of Life (QoL)
baseline and every 3 months using EORTC QLQ-C30
Measured: 3 years
Quality of Life (QoL)
baseline and every 3 months using EORTC QLQ-HCC18
Measured: 3 years
Treatment-Related Adverse Events (AEs)
from consent through 30 days after last radiotherapy (Serious Adverse Event reporting up to 90 days post-radiotherapy)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start30 Nov 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Nov 2028 (estimated)
Why it stopped: Difficult to recruit patients
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274774
- Sponsor's protocol ID
- SDZLEC2025-074-02
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2025
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Therapy Combined With Stereotactic Body Radiotherapy Versus Systemic Therapy Alone in BCLC Stage C Hepatocellular Carcinoma (SCRATCH): A Prospective, Multicenter, Phase II, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07274774
- Acronym / sponsor ID
- SDZLEC2025-074-02
- Keywords
- hepatocellular carcinoma, BCLC stage C, metastasis, radiotheraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficult to recruit patients
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Nov 2028 (estimated)
- First posted
- 10 Dec 2025 (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.
This prospective, multicenter, phase II randomized controlled trial compares the efficacy and safety of SBRT combined with systemic therapy versus systemic therapy alone in BCLC stage C hepatocellular carcinoma (HCC). The primary objective is to compare overall survival (OS) between the two arms. Secondary objectives include progression-free survival (PFS), objective response rate (ORR), quality of life (QoL), and incidence and severity of adverse events (AEs). Eligible patients will be randomized 2:1 to an experimental arm (SBRT + systemic therapy) or control arm (systemic therapy alone). Key inclusion criteria include BCLC C disease, Child-Pugh A-B liver function, ECOG ≤2, measurable disease per RECIST 1.1, and stable intrahepatic disease after initial systemic therapy for ≥3 months when applicable. The trial will also include predefined safety monitoring, QoL assessments (EORTC QLQ-C30 and QLQ-HCC18), and exploratory biomarker analyses.
Detailed description
Background: Hepatocellular carcinoma (HCC) is frequently diagnosed at advanced stages with limited curative options. Systemic therapies (targeted agents and immune checkpoint inhibitors) have improved outcomes in BCLC C patients, but their therapeutic effect is unsatisfactory. SBRT provides precise high-dose local control and may synergize with systemic therapy by enhancing tumor immunogenicity and improving local disease control.
Study design: Prospective, randomized, open-label, multicenter Phase II trial. In the experimental arm, patients will continue the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines, combined with SBRT delivered to portal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic metastatic lesions. In the control arm, patients will continue the same guideline-recommended systemic treatment without SBRT.
Endpoints: The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR by RECIST 1.1 and mRECIST), disease control rate (DCR), duration of response (DoR), quality of life (EORTC QLQ-C30 and QLQ-HCC18), and safety (CTCAE v5.0). Exploratory endpoints may include biomarker dynamics (e.g., immune cell infiltration, viral markers) and patterns of progression.
Safety and monitoring: AEs will be collected from consent through 30 days after the last radiotherapy; SAEs will be reported per protocol (including deaths up to 90 days after radiotherapy). Regular imaging and clinical assessments will monitor efficacy and safety. Data management and monitoring will follow GCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Systemic therapy, Radiation: RadiotherapySBRT + Systemic Therapy |
| Control | Other | Drug: Systemic therapySystemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-70 years.
- Histologically or clinically diagnosed HCC per national guidelines.
- BCLC stage C (CNLC IIIA/IIIB), including PVTT and/or extrahepatic metastases amenable to protocol procedures.
- Child-Pugh class A or B (score ≤7).
- At least one measurable lesion per RECIST 1.1 (criteria specified).
Key exclusion criteria (10 listed)
- Second primary malignancy (exceptions apply).
- Tumor thrombus/metastases judged not amenable to radiotherapy.
- Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).
- Severe organ dysfunction precluding treatment.
- Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
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 |
|---|---|---|
| Systemic therapySystemic therapy will consist of the continuation of the guideline-recommended systemic treatment received prior to enrollment, in accordance with approved labels and national guidelines | Drug | Control, Treatment |
| Radiotherapyportal vein tumor thrombus (PVTT, if present) and/or limited extrahepatic active lesions. For patients presenting with more than 10 lesions at baseline (including extrahepatic metastases with or without portal vein tumor thrombus), a comprehensive FDG-PET/CT reassessment of the whole body is required after 3 months of systemic therapy. Patients who demonstrate ≤10 active lesions at this reassessment may then be considered eligible for SBRT. Dose and fractionation: total dose 25-40 Gy delivered in 5 fractions (5-8 Gy per fraction). Dose selection individualized based on tumor size, location and nearby organ-at-risk constraints; sequential or staged SBRT allowed. | Radiation | Treatment |
Primary outcome
Overall Survival (OS)
Time frame: subjects will be followed up for a minimum combined accrual + follow-up period of 48 months (24-month enrollment + 24-month follow-up planned)
Time from date of randomization to date of death from any cause
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of Response (DoR)
Time frame: 2 years
Quality of Life (QoL)
Time frame: 3 years
Quality of Life (QoL)
Time frame: 3 years
Treatment-Related Adverse Events (AEs)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
Not yet recruitingPhase 3
Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Hepatocellular Carcinoma, HCC
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Systemic therapy and Radiotherapy in people with Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, run by Shandong Cancer Hospital and Institute 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 12 inclusion and 10 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: paused, as of the sponsor's last update on 15 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: subjects will be followed up for a minimum combined accrual + follow-up period of 48 months (24-month enrollment + 24-month follow-up planned)). 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 15 Oct 2026.