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Compares treatment options for Hepatocellular Carcinoma
Official title SBRT Plus Systemic Therapy vs Systemic Therapy Alone in BCLC C Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07274774
What this study is testing
What is Systemic therapy?
Systemic therapy is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
- Significant neurologic dysfunction.
- Pregnant or breastfeeding women; no effective contraception.
- Known hypersensitivity to planned drugs.
- Any other condition making participation unsuitable per investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.