Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how radiotherapy can help patients with advanced liver cancer, specifically those who have oligometastatic hepatocellular carcinoma (HCC), which means their cancer has spread but is still limited to a few areas. The trial aims to see if combining radiotherapy with existing drug therapies can improve treatment outcomes and allow for a delay in starting second-line drug therapies, which typically provide only a few months of benefit.

To participate in this trial, individuals must be between 18 and 75 years old, have a confirmed diagnosis of primary liver cancer, and have stable disease after at least three months of systemic therapy. Participants will undergo treatment while being closely monitored for how well the combination of therapies works and any side effects. It's important to note that people with certain health conditions, recent cancer treatments, or specific infections may not be eligible. This trial represents an exciting opportunity for patients with limited treatment options to potentially benefit from a new approach in managing their condition.

Gender

ALL

Eligibility 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.