1.1. Main Objectives The objective response rate (ORR) determined by the researchers based on RECIST v1.1 was used to evaluate the efficacy of systemic therapy (carrycept combined with apatinib) in combination with or without local treatment (surgery, radiotherapy, or ablation therapy) for patients with advanced hepatocellular carcinoma with pulmonary metastases.
1.2. Secondary objectives Through efficacy indicators such as progression-free survival (PFS) and objective response rate (ORR) determined by researchers based on RECIST v1.1 and mRECIST, evaluate the efficacy of systemic therapy (carrietumab combined with apatinib) combined or not with local treatment (surgery, radiotherapy, or ablation therapy) for patients with advanced hepatocellular carcinoma with pulmonary metastases.
Evaluate the safety of combining systemic therapy (caretuximab-rbsm in combination with apatinib) with or without local treatment (surgery, radiotherapy, or ablation therapy) for patients with advanced hepatocellular carcinoma with pulmonary metastases.
1.3. Exploratory Purpose Evaluate the cumulative duration (the sum of the time spent in a NED state) and the safety of local treatments for patients who have undergone comprehensive treatment and have no detectable active lesions on imaging studies (NED).
Explore the correlation between biomarkers and the efficacy of combined treatment regimens.
Explore the relationship between the number, diameter, and treatment outcomes of pulmonary metastases in hepatocellular carcinoma.
The patient voluntarily participates in this study and signs an informed consent form.
Age: 18 to 85 years old, both male and female are eligible.
Patients with hepatocellular carcinoma (HCC) confirmed through histopathological examination of tumor tissue or imaging assessments [refer to the Guidelines for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2024 Edition)].
There are extrahepatic pulmonary metastases that have not been treated locally, and the number of these metastases is ≤5.
Known cases of cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar cell carcinoma; having had an active malignant tumor other than HCC within 5 years or concurrently. Limited-stage tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial carcinoma, cervical intraepithelial carcinoma, and breast intraepithelial carcinoma, can be included.
Has previously received anti-cancer treatments targeting metastatic lesions.
The site of extrahepatic metastasis is not the lungs, or there are more than 2 distant metastasized organs (including 2).
Suffering from any severe infection, serious mental or physical illness, or laboratory test abnormalities that are uncontrollable, which may pose an unacceptable risk, negatively impact trial compliance, or affect the administration, distribution, metabolism, and excretion of the investigational drug. Examples include unstable heart disease, chronic kidney disease, poorly controlled diabetes, mood disorders, mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, and pleural effusions requiring treatment.
Pulmonary metastases are the most common type of extrahepatic metastasis in liver cancer, accounting for approximately 40%. Patients with this condition have poor prognoses, with a total survival period of only 6 to 10 months. The overall survival rate at one year and the cancer-specific survival rate are only 12.8% and 15.3%, respectively. Therefore, improving the treatment outcomes for patients with pulmonary metastases from liver cancer has become a research focus and challenge. This study prospectively collected data on the efficacy and safety of systemic treatment (carryliqumab combined with apatinib) and/or local treatments (surgery, radiotherapy, or ablation therapy) for patients with locally advanced or metastatic hepatocellular carcinoma that has not been treated systemically.
Cohort
Prospective
Not listed
Objective response rate
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