Actively Recruiting
Continuation of First-line Therapy With Radiotherapy Versus Early Switch to Second-line Therapy in Oligoprogressive HCC
Led by Shandong Cancer Hospital and Institute · Updated on 2025-08-01
132
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, prospective, randomized, controlled, open-label, two-arm Phase III clinical trial is designed to evaluate whether adding radiotherapy to oligoprogressive lesions while continuing first-line systemic therapy at the time of oligoprogression can effectively prolong progression-free survival compared to early switching to second-line systemic therapy in oligoprogressive hepatocellular carcinoma.
CONDITIONS
Official Title
Continuation of First-line Therapy With Radiotherapy Versus Early Switch to Second-line Therapy in Oligoprogressive HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of primary hepatocellular carcinoma (HCC) by histology, cytology, or clinical guidelines.
- BCLC stage C at the start of first-line systemic treatment.
- Oligoprogression confirmed during first-line systemic therapy with 1 to 5 progressing lesions in 1 to 3 organs.
- Experienced oligoprogression while on current first-line systemic therapy that maintained stable disease for at least 3 months.
- At least one measurable oligoprogressive lesion eligible for radiotherapy.
- Liver function with Child-Pugh score 7 or lower.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Ability to understand and sign informed consent and comply with study procedures.
- Age between 18 and 75 years.
- Availability of tumor and blood samples for biomarker studies.
You will not qualify if you...
- Received first-line systemic therapy as adjuvant treatment after curative liver surgery.
- Tumor progression within 3 months after starting first-line systemic therapy.
- Diagnosis of combined hepatocellular-cholangiocarcinoma.
- History of severe adverse events (grade 3 or higher) from first-line systemic therapy.
- Presence of brain, peritoneal, or omental metastases with bleeding after first-line therapy.
- Prior radiation therapy to the oligoprogressive lesion sites.
- Active untreated hepatitis B infection with elevated viral DNA levels.
- Oligoprogressive lesions not suitable for radiotherapy.
- Alpha-fetoprotein levels above 10,000 ng/mL at oligoprogression.
- Other cancers diagnosed within 3 years except certain skin cancers and carcinoma in situ.
- Participation in other interventional studies or investigational treatments within 4 weeks before enrollment.
- Autoimmune diseases or conditions needing long-term steroid use.
- Severe organ impairment or active infections other than viral hepatitis.
- Known allergies to study drugs.
- History of organ transplantation.
- Pregnant or breastfeeding women.
- Any condition that may affect study participation or result evaluation as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Jinan, Shandong 0531
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jinbo Yue, Doctor
CONTACT
J
Jinbo Yue, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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