Efficacy and Safety of Camrelizumab Plus Rivoceranib and Local Therapy for Hepatocellular Carcino… (NCT07482670) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Camrelizumab Plus Rivoceranib and Local Therapy for Hepatocellular Carcinoma With Lung Metastases (CAPLocal) : A Multicentre, Single-Arm,Prospective Cohort Study
32 participantsStarted 2026-03-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Has not received any form of systematic treatment for HCC.
. There must be at least one measurable lesion (according to the RECIST v1.1 criteria, this measurable lesion must have a longitudinal diameter ≥ 10 mm on spiral CT scans or a short diameter ≥ 15 mm for enlarged lymph nodes; lesions that have previously received local treatment and have clearly progressed according to the RECIST v1.1 standards can be considered target lesions).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: From enrollment to the end of treatment at Week 12
Trial details
NCT IDNCT07482670
SponsorXiangya Hospital of Central South University
. Neutrophil-to-lymphocyte ratio (NLR) of less than or equal to 3.
. The Child Pugh liver function classification is Grade A or B (≤7).
Exclusion criteria
. 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.
. Suffers from hypertension and cannot achieve adequate control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). It is permissible to use antihypertensive treatment to achieve these parameters. Has previously experienced a hypertensive crisis or hypertensive encephalopathy.
. Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) (or active viral hepatitis).
. Received experimental treatments from other clinical studies concurrently during the course of this trial.
. Long-term use of immunosuppressive agents following organ transplantation.