Radiotherapy for patients with advanced liver cancer
Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer: a Multicenter, Single-arm, Phase II Clinical Trial.
This study tests if adding radiotherapy can help people with advanced liver cancer delay the need for more aggressive drug treatments after their initial therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Cancer Hospital and Institute Academic / other |
| Drugs / interventions | ramucirumab, atezolizumab, bevacizumab, lenvatinib, cabozantinib, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06261047 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of radiotherapy on patients with oligoprogressive hepatocellular carcinoma (HCC) who have previously undergone systemic therapy. It aims to evaluate how radiotherapy can delay the need for second-line drug therapy in this patient population. The study includes patients with a specific staging of HCC and assesses their liver function and overall health status. By combining radiotherapy with existing treatment strategies, the study seeks to improve patient outcomes in a challenging treatment landscape.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with oligometastatic HCC and stable disease after systemic therapy.
Not a fit: Patients with other malignancies or those with poor liver function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could extend the time before patients need to switch to second-line therapies, potentially improving their quality of life.
How similar studies have performed: While the combination of radiotherapy and immunotherapy has shown promise in other studies, this specific approach in oligoprogressive HCC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Obtain written informed consent before implementing any trial-related procedures. * Male or female, aged 18 years or older, and 75 years or younger. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. * Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosed according to the Clinical Diagnosis and Treatment Guidelines for Primary - Liver Cancer (2019 edition) issued by the National Health Commission of the People's Republic of China. * Tumor staged as BCLC stage C; patients have ≤5 lesions (≤3 affected organs) with oligometastasis or oligoprogression. * Liver function assessed by Child-Pugh score ≤7 points. * Availability of tumor samples for biomarker assessment. * Stable disease with systemic therapy for ≥3 months and an anticipated survival period of ≥6 months. Exclusion Criteria: * Diagnosis of malignancy other than liver cancer within 3 years before enrollment (excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma). * Currently participating in interventional clinical research treatment, or received other investigational drugs or investigational device therapy within the past 4 weeks before enrollment. * Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before enrollment (including thymosin, interferon, interleukin, except for local use to control pleural effusion). * Experienced active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years before enrollment. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment. * Received radiotherapy within 2 weeks before enrollment. * HIV + * Active untreated hepatitis B (defined as HBsAg positive with HBV-DNA copy number exceeding the upper limit of normal value in the laboratory of the participating center). * Pregnant or lactating women.
Where this trial is running
Jinan, Shandong
- Jinbo Yue — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: jibo yue, dorctor — Shandong Cancer Hospital and Institute
- Study coordinator: jinbo yue, dorctor
- Email: yuejinbo@hotmail.com
- Phone: +86053167626442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.