Adding SBRT (high‑precision radiotherapy) to standard systemic treatment for advanced (BCLC C) liver cancer

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 trial tests whether giving targeted high-dose radiotherapy (SBRT) in addition to standard systemic drugs helps people with advanced BCLC C hepatocellular carcinoma live longer than systemic therapy alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07274774 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, open-label Phase II trial comparing SBRT plus ongoing guideline-recommended systemic therapy versus systemic therapy alone in patients with BCLC C hepatocellular carcinoma. Eligible participants (2:1 randomization) continue their approved systemic treatment and, in the experimental arm, receive SBRT to portal vein tumor thrombus and/or limited extrahepatic metastatic lesions; the control arm continues systemic therapy without SBRT. The primary endpoint is overall survival, with secondary endpoints including progression-free survival, objective response rate (RECIST 1.1 and mRECIST), quality of life (EORTC QLQ-C30 and QLQ-HCC18), and safety (CTCAE v5.0); exploratory biomarker analyses are planned. Safety monitoring and QoL assessments are performed throughout treatment and follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults (18–70) with BCLC stage C HCC (including PVTT and/or limited extrahepatic metastases amenable to radiotherapy), Child‑Pugh A–B (≤7), ECOG ≤2, at least one measurable lesion per RECIST 1.1, and expected survival ≥6 months.

Not a fit: Patients whose tumors are not amenable to radiotherapy, who have severe organ dysfunction or very limited life expectancy, or who meet exclusion criteria (such as certain second primaries) are unlikely to benefit from the SBRT addition.

Why it matters

Potential benefit: If successful, adding SBRT could improve overall survival and local disease control for patients with advanced BCLC C HCC.

How similar studies have performed: Smaller and retrospective series suggest SBRT improves local control and may synergize with systemic therapy, but randomized evidence specifically in BCLC C patients remains limited.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years.
2. Histologically or clinically diagnosed HCC per national guidelines.
3. BCLC stage C (CNLC IIIA/IIIB), including PVTT and/or extrahepatic metastases amenable to protocol procedures.
4. Child-Pugh class A or B (score ≤7).
5. At least one measurable lesion per RECIST 1.1 (criteria specified).
6. ECOG ≤2.
7. Expected survival ≥6 months.
8. Adequate organ function per protocol thresholds.
9. For experimental arm candidates: active lesion count (when PET-CT used) ≤10.
10. If prior initial systemic therapy given: intrahepatic disease stable ≥3 months.
11. Effective contraception from consent through 1 year after treatment end.
12. Ability to understand and sign consent.

Exclusion Criteria:

1. Second primary malignancy (exceptions apply).
2. Tumor thrombus/metastases judged not amenable to radiotherapy.
3. Prior systemic anticancer therapy for current HCC (prior local therapy permitted per rules).
4. Severe organ dysfunction precluding treatment.
5. Uncontrolled comorbidities (e.g., uncontrolled diabetes, active peptic ulcer, severe cardiopulmonary disease).
6. Active uncontrolled infection or active autoimmune disease requiring systemic therapy.
7. Significant neurologic dysfunction.
8. Pregnant or breastfeeding women; no effective contraception.
9. Known hypersensitivity to planned drugs.
10. Any other condition making participation unsuitable per investigator.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital and Institute — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Jinbo Yue, doctor

Conditions Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; hepatocellular carcinoma; BCLC stage C; metastasis; radiotheraphy