Efficacy and Safety of Camrelizumab Plus Rivoceranib and Local Therapy for Hepatocellular Carcinoma With Lung Metastases (CAPLocal) : A Multicentre, Single-Arm,Prospective Cohort Study

March 15, 2026 updated by: Xiangya Hospital of Central South University

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study:

  1. The patient voluntarily participates in this study and signs an informed consent form.
  2. Age: 18 to 85 years old, both male and female are eligible.
  3. 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)].
  4. There are extrahepatic pulmonary metastases that have not been treated locally, and the number of these metastases is ≤5.
  5. Has not received any form of systematic treatment for HCC.
  6. 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).
  7. Neutrophil-to-lymphocyte ratio (NLR) of less than or equal to 3.
  8. The Child Pugh liver function classification is Grade A or B (≤7).
  9. The Eastern Cooperative Oncology Group (ECOG) behavioral status is 0 or 1 for patients in the eastern United States.
  10. Good lung function, expected to be able to tolerate surgery or localized treatment.

  11. Other major organ functions are generally normal (the blood system, kidneys, etc., function well).

    Muscular marrow function is adequate: white blood cell count ≥ 4.0 × 10^9/L, absolute neutrophil count (ANC) ≥ 2.0 × 10^9 / L, platelet count ≥ 100 × 10 ^ 9 / L, hemoglobin concentration ≥ 90 g/L (no blood transfusions, no use of hematopoietic factors, and no medication correction within 2 weeks prior to the first administration).

    For patients not receiving anticoagulant therapy, the INR (International Normalized Ratio) and APTI (Activated Partial Thromboplastin Time) values are ≤ 1.5 times the upper limit of normal.

    Sufficient renal function: creatinine clearance ≥ 60 mL/min.

  12. Patients with active hepatitis B virus (HBV) infection must receive anti-HBV treatment prior to the initiation of the study treatment and must be willing to undergo antiviral therapy throughout the study period. Patients with hepatitis C virus (HCV) RNA-positive status must receive antiviral treatment according to local standard treatment guidelines and have liver function levels within the range of CTCAE Grade 1 elevation.
  13. Women of childbearing age should have a negative serum or urine pregnancy test within 7 days prior to enrollment in the study, and must be non-lactating patients who have given their consent to use contraceptive measures during the study period and for 6 months after its completion. Men must agree to use contraceptive measures both during the study period and within 6 months after its conclusion.
  14. The participant voluntarily consents to receive treatment related to this clinical study and agrees to participate in follow-up assessments.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible to participate in this study:

  1. 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.
  2. Has previously received anti-cancer treatments targeting metastatic lesions.
  3. The site of extrahepatic metastasis is not the lungs, or there are more than 2 distant metastasized organs (including 2).
  4. 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.
  5. 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.
  6. Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) (or active viral hepatitis).
  7. Received experimental treatments from other clinical studies concurrently during the course of this trial.
  8. Long-term use of immunosuppressive agents following organ transplantation.
  9. According to the researchers' assessment, the subject may have other factors that could lead to the forced discontinuation of this study. These include non-compliance with the protocol, the presence of other serious conditions (including mental illnesses) requiring concurrent treatment, significant laboratory abnormalities, a history of substance abuse or drug use, combined with psychological, social, familial, or geographic factors, which could impact the subject's safety or the collection of data and samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Camrelizumab plus Rivoceranib and Local Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: From enrollment to the end of treatment at Week 12
From enrollment to the end of treatment at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 202602023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be made available to other researchers upon reasonable request, following approval of a formal research proposal, and in compliance with applicable ethical and legal requirements.

IPD Sharing Time Frame

IPD will be made available beginning 6 months after publication of the primary study results, and will be accessible for a period of 5 years thereafter.

IPD Sharing Access Criteria

De-identified IPD and supporting documents will be accessible to qualified researchers upon reasonable request, following review and approval of a formal research proposal. Access will be provided in compliance with ethical approval, informed consent, and applicable laws and regulations. Data will be shared via a secure, password-protected data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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