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Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC (HLP1-1331)

19 de maio de 2026 atualizado por: TingBo Liang, Zhejiang University

Multimodal Thermal Therapy With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone for Systemically Untreated Unresectable (HCC): a Prospective, Multicenter, Open-label, Randomized Controlled Trial.

Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This prospective, multicenter, open-label, randomized controlled study is titled "Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)". The research aims to evaluate the clinical benefits of combining local intervention with systemic treatments. The primary objective is to compare the progression-free survival (PFS) between the combination therapy and standard systemic therapy. Secondary objectives include assessing the objective response rate (ORR), disease control rate (DCR), overall survival (OS), pain levels via VAS scores, and general safety. Furthermore, the study includes an exploratory goal of monitoring changes in peripheral blood immune indicators to analyze the impact of the combined treatment on the patient's immune function. The study aims to enroll a total of 166 patients, who are randomized in a 1:1 ratio into either an experimental group or a control group, resulting in 83 participants per arm. Eligible participants are adults aged 18 to 80 with unresectable HCC staged as BCLC B or C who have not previously received systemic drug therapy. Inclusion requires a Child-Pugh score of 7 or less, an ECOG-PS score of 0 to 1, and at least one evaluable lesion suitable for ablation with a maximum diameter of 5 cm. Patients are excluded if they have portal vein main trunk invasion, diffuse HCC, symptomatic brain metastases, or extensive distant metastases.

Tipo de estudo

Intervencional

Inscrição (Estimado)

166

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Henan
      • Kaifeng, Henan, China
        • Huaihe Hospital of Henan University
        • Contato:
        • Investigador principal:
          • Li Zexin, doctor's degree
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
        • Contato:
          • Wang Kai, Doctor
          • Número de telefone: +86 13767104812
          • E-mail: neswk@163.com
        • Investigador principal:
          • Wang Kai, doctor's degree
    • Zhejiang Provinece
      • Hangzhou, Zhejiang Provinece, China
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contato:
        • Investigador principal:
          • Liang Tingbo, doctor's degree
      • Yiwu, Zhejiang Provinece, China
        • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
        • Contato:
          • Tang Zhe, Doctor
          • Número de telefone: +86 18867961022
          • E-mail: 8xi@zju.edu.cn
        • Investigador principal:
          • Tang Zhe, doctor's degree

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • • Age 18-80, regardless of gender;

    • Diagnosed with unresectable HCC by imaging or histology, BCLC stage B or C;
    • No prior systemic immunotherapy, chemotherapy, targeted therapy, or other systemic drug treatments for HCC;
    • Presence of an image-evaluable lesion intended for ablation without prior local ablation therapy, with the maximum diameter of the target tumor ≤5 cm;
    • Child-Pugh score ≤7;
    • ECOG-PS score of 0-1.

Exclusion Criteria:

  • • Invasion of the main portal vein;

    • Diffuse hepatocellular carcinoma;
    • Patients with a history or current diagnosis of brain metastases whose symptoms are not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustments to symptomatic treatment to maintain symptom relief);
    • Extensive distant metastasis confirmed by imaging (e.g., chest/abdominal CT/MRI, whole-body bone scan, PET-CT, etc.), including but not limited to diffuse lung metastasis, multiple bone metastases, extensive abdominal/peritoneal metastasis, or other multi-organ metastases, where the investigator assesses that the extent of metastasis may compromise the safe administration of study treatment or affect efficacy and safety evaluations;
    • Prior local therapy with the last treatment administered less than 4 weeks before enrollment;
    • Involvement of major blood vessels such as the hepatic vein or inferior vena cava;
    • Uncontrolled active infection;
    • Renal dysfunction with serum creatinine >176.8 μmol/L or creatinine clearance <30 mL/min;
    • Uncorrectable coagulation abnormalities: platelets <50×10⁹/L, prothrombin time >18 seconds, prothrombin activity <40%, and uncorrectable;
    • History of esophageal or gastric variceal bleeding without effective treatment via endoscopy, intervention, or surgery;
    • Patients with active psychiatric disorders;
    • Patients receiving or requiring systemic glucocorticoids (e.g., prednisone, dexamethasone) at a dose ≥10 mg/day (prednisone equivalent) or other immunosuppressive drugs (e.g., cyclosporine, tacrolimus, methotrexate) within 14 days prior to enrollment; topical, inhaled, or ophthalmic glucocorticoid use that does not affect systemic immune function may be allowed at the investigator's discretion;
    • History or current diagnosis of malignancies other than the target tumor in this study (excluding cured low-grade malignancies such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ). For low-grade malignancies, eligibility will be determined by the investigator;
    • Pregnant or breastfeeding women, or women of childbearing potential planning pregnancy during the study or within 3 months after treatment completion;
    • Expected survival <3 months;
    • Patients deemed unsuitable for participation by the investigator.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Experimental group
Multimodal Thermal Therapy Combined with Targeted and Immune Drugs
Dispositivo: Multimodal Thermal Therapy
Multimodal Thermal Therapy (MTT) is an advanced ablation technique that utilizes an integrated microprobe to combine liquid nitrogen freezing with radiofrequency heating. This dual-action process creates a rapidly shifting temperature field and significant tissue stress, leading to the complete destruction of tumor cells and their associated blood vessels. Beyond local tumor removal, the procedure acts as an "in situ vaccine" by releasing tumor-associated antigens and danger signals into the bloodstream, which activates a systemic and durable anti-tumor immune response.
Medicamento: Targeted and Immune Drugs
In this research, systemic treatment specifically refers to the combination of targeted therapies and immune checkpoint inhibitors, such as PD-1 inhibitors. These drugs are selected based on their approval by the NMPA for liver cancer treatment and the specific clinical needs of the patient. The primary role of the immune drugs is to block immune checkpoints, which prevents the tumor from escaping the body's defenses and significantly enhances the natural anti-tumor function of T cells. Complementing this, the targeted drugs-often anti-angiogenic agents-work to inhibit tumor blood vessel growth and improve the overall immune microenvironment. When used together, they create a synergistic "dual" effect: the targeted drugs optimize the environment for immune cell infiltration while the immune drugs activate T cells to more effectively attack the cancer.
Comparador Ativo: Control Group
Targeted and Immune Drugs
Medicamento: Targeted and Immune Drugs
In this research, systemic treatment specifically refers to the combination of targeted therapies and immune checkpoint inhibitors, such as PD-1 inhibitors. These drugs are selected based on their approval by the NMPA for liver cancer treatment and the specific clinical needs of the patient. The primary role of the immune drugs is to block immune checkpoints, which prevents the tumor from escaping the body's defenses and significantly enhances the natural anti-tumor function of T cells. Complementing this, the targeted drugs-often anti-angiogenic agents-work to inhibit tumor blood vessel growth and improve the overall immune microenvironment. When used together, they create a synergistic "dual" effect: the targeted drugs optimize the environment for immune cell infiltration while the immune drugs activate T cells to more effectively attack the cancer.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free survival (PFS) per mRECIST
Prazo: Up to ~24 months.
Progression-free survival (PFS) was defined as the interval from randomization to initial confirmed disease progression or all-cause death, whichever came first, with tumor assessments conducted per mRECIST by on-site investigators.
Up to ~24 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate (ORR) per mRECIST
Prazo: Up to ~24 months.
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions), with tumor assessments conducted per mRECIST by on-site investigators.
Up to ~24 months.
Objective Response Rate (ORR) per RECIST 1.1
Prazo: Up to ~24 months.
Objective response rate (ORR) was defined as the proportion of participants achieving confirmed complete response or partial response, with tumor assessments conducted per RECIST 1.1 by on-site investigators.
Up to ~24 months.
Progression-free survival (PFS) per RECIST 1.1
Prazo: Up to ~24 months.
Progression-free survival (PFS) was defined as the interval from randomization to initial confirmed disease progression or all-cause death, whichever came first, with tumor assessments conducted per RECIST 1.1 by on-site investigators.
Up to ~24 months.
Overall Survival
Prazo: Up to ~36 months.
Overall survival (OS) was defined as the time from randomization to all-cause death, with outcome assessments conducted by on-site investigators.
Up to ~36 months.
Disease Control Rate (DCR) per RECIST 1.1
Prazo: Up to ~24 months.
Disease control rate (DCR) was defined as the proportion of participants achieving confirmed complete response, partial response or stable disease, with tumor assessments conducted per RECIST 1.1 by on-site investigators.
Up to ~24 months.
Disease Control Rate (DCR) per mRECIST
Prazo: Up to ~24 months.
Disease control rate (DCR) was defined as the proportion of participants achieving confirmed complete response, partial response or stable disease, with tumor assessments conducted per mRECIST by on-site investigators.
Up to ~24 months.
Visual Analogue Scale
Prazo: During the MTT procedure only.
The VAS score ranges from 0 to 10, with 0 indicating no pain at all and 10 representing the worst possible pain.
During the MTT procedure only.
Percentage of Participants Who Experience At Least One Adverse Event (AE)
Prazo: Up to ~36 months.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
Up to ~36 months.
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
Prazo: Up to ~36 months.
An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.
Up to ~36 months.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Zhejiang University

Investigadores

  • Investigador principal: Liang Tingbo, doctor's degree, Zhejiang University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

25 de maio de 2026

Conclusão Primária (Estimado)

25 de maio de 2028

Conclusão do estudo (Estimado)

25 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

2 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • HLP1-1331

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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