Hepatecellular CarcinomaNCT07482670
Efficacy and Safety of Camrelizumab Plus Rivoceranib and Local Therapy for Hepatocellular Carcinoma With Lung Metastases (CAPLocal) : A Multicentre, Single-Arm,Prospective Cohort Study
An observational study of Hepatecellular Carcinoma, run by Xiangya Hospital of Central South University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatecellular Carcinoma
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients must meet all of the following inclusion criteria in order to be eligible for participation in this study:
- 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.
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- 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).
- Neutrophil-to-lymphocyte ratio (NLR) of less than or equal to 3.
- The Child Pugh liver function classification is Grade A or B (≤7).
- The Eastern Cooperative Oncology Group (ECOG) behavioral status is 0 or 1 for patients in the eastern United States.
- Good lung function, expected to be able to tolerate surgery or localized treatment.
- 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.
- 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.
- 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.
- The participant voluntarily consents to receive treatment related to this clinical study and agrees to participate in follow-up assessments.
Who cannot join
- Patients who meet any of the following criteria will not be eligible to participate in this study:
- 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.
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- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Hepatecellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus Rivoceranib and Local Therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From enrollment to the end of treatment at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Hepatecellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482670
- Sponsor's protocol ID
- 202602023
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Wu C, Ren X, Zhang Q. Incidence, risk factors, and prognosis in patients with primary hepatocellular carcinoma and lung metastasis: a population-based study. Cancer Manag Res. 2019 Apr 8;11:2759-2768. doi: 10.2147/CMAR.S192896. eCollection 2019.
PubMed 31040715Reig M, Sanduzzi-Zamparelli M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Diaz A, Llarch N, Iserte G, Molla M, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Yanagihara TK, Ayuso C, Torres F, Bruix J. BCLC strategy for prognosis prediction and treatment recommendations: The 2026 update. J Hepatol. 2026 Mar;84(3):631-654. doi: 10.1016/j.jhep.2025.10.020. Epub 2025 Oct 27.
PubMed 41151697Vogel A, Chan SL, Dawson LA, Kelley RK, Llovet JM, Meyer T, Ricke J, Rimassa L, Sapisochin G, Vilgrain V, Zucman-Rossi J, Ducreux M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Hepatocellular carcinoma: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025 May;36(5):491-506. doi: 10.1016/j.annonc.2025.02.006. Epub 2025 Feb 20. No abstract available.
PubMed 39986353Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.
PubMed 33087333Zhao S, Ren S, Jiang T, Zhu B, Li X, Zhao C, Jia Y, Shi J, Zhang L, Liu X, Qiao M, Chen X, Su C, Yu H, Zhou C, Zhang J, Camidge DR, Hirsch FR. Low-Dose Apatinib Optimizes Tumor Microenvironment and Potentiates Antitumor Effect of PD-1/PD-L1 Blockade in Lung Cancer. Cancer Immunol Res. 2019 Apr;7(4):630-643. doi: 10.1158/2326-6066.CIR-17-0640. Epub 2019 Feb 12.
PubMed 30755403Llovet JM, Kudo M, Merle P, Meyer T, Qin S, Ikeda M, Xu R, Edeline J, Ryoo BY, Ren Z, Masi G, Kwiatkowski M, Lim HY, Kim JH, Breder V, Kumada H, Cheng AL, Galle PR, Kaneko S, Wang A, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS; LEAP-002 Investigators. Lenvatinib plus pembrolizumab versus lenvatinib plus placebo for advanced hepatocellular carcinoma (LEAP-002): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Dec;24(12):1399-1410. doi: 10.1016/S1470-2045(23)00469-2.
PubMed 38039993Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.
PubMed 37499670Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, Chan SL, Melkadze T, Sukeepaisarnjaroen W, Breder V, Verset G, Gane E, Borbath I, Rangel JDG, Ryoo BY, Makharadze T, Merle P, Benzaghou F, Banerjee K, Hazra S, Fawcett J, Yau T. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. doi: 10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4.
PubMed 35798016Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15.
PubMed 34143971Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.
PubMed 32402160Sakamoto Y, Kubota K, Mori M, Inoue K, Abe H, Harihara Y, Bandai Y, Makuuchi M. Surgical management for adrenal gland metastasis of hepatocellular carcinoma. Hepatogastroenterology. 1999 Mar-Apr;46(26):1036-41.
PubMed 10370663Hu Z, Li W, Huang P, Zhou Z, Xu J, Xu K, Wang J, Zhang H. Therapeutic significance and indications of pulmonary metastasectomy for hepatocellular carcinoma following liver resection. Int J Surg. 2017 Dec;48:23-31. doi: 10.1016/j.ijsu.2017.09.075. Epub 2017 Oct 5.
PubMed 28987561Ikegami T, Yoshizumi T, Kawasaki J, Nagatsu A, Uchiyama H, Harada N, Harimoto N, Itoh S, Motomura T, Soejima Y, Maehara Y. Surgical Resection for Lymph Node Metastasis After Liver Transplantation for Hepatocellular Carcinoma. Anticancer Res. 2017 Feb;37(2):891-895. doi: 10.21873/anticanres.11395.
PubMed 28179348Soliman H, Ringash J, Jiang H, Singh K, Kim J, Dinniwell R, Brade A, Wong R, Brierley J, Cummings B, Zimmermann C, Dawson LA. Phase II trial of palliative radiotherapy for hepatocellular carcinoma and liver metastases. J Clin Oncol. 2013 Nov 1;31(31):3980-6. doi: 10.1200/JCO.2013.49.9202. Epub 2013 Sep 23.
PubMed 24062394Kashima M, Yamakado K, Takaki H, Kaminou T, Tanigawa N, Nakatsuka A, Takeda K. Radiofrequency ablation for the treatment of bone metastases from hepatocellular carcinoma. AJR Am J Roentgenol. 2010 Feb;194(2):536-41. doi: 10.2214/AJR.09.2975.
PubMed 20093621