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

2026年5月19日 更新者：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)

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

166

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Henan
      • Kaifeng、Henan、中国
        • Huaihe Hospital of Henan University
        • コンタクト：
        • 主任研究者：
          • Li Zexin, doctor's degree
    • Jiangxi
      • Nanchang、Jiangxi、中国
        • The Second Affiliated Hospital of Nanchang University
        • コンタクト：
          • Wang Kai, Doctor
          • 電話番号：+86 13767104812
          • メール：neswk@163.com
        • 主任研究者：
          • Wang Kai, doctor's degree
    • Zhejiang Provinece
      • Hangzhou、Zhejiang Provinece、中国
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • コンタクト：
        • 主任研究者：
          • Liang Tingbo, doctor's degree
      • Yiwu、Zhejiang Provinece、中国
        • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
        • コンタクト：
          • Tang Zhe, Doctor
          • 電話番号：+86 18867961022
          • メール：8xi@zju.edu.cn
        • 主任研究者：
          • Tang Zhe, doctor's degree

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Experimental group
Multimodal Thermal Therapy Combined with Targeted and Immune Drugs
デバイス：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.
薬：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.
アクティブコンパレータ：Control Group
Targeted and Immune Drugs
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-free survival (PFS) per mRECIST
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) per mRECIST
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Zhejiang University

捜査官

  • 主任研究者：Liang Tingbo, doctor's degree、Zhejiang University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月25日

一次修了 (推定)

2028年5月25日

研究の完了 (推定)

2029年5月25日

試験登録日

最初に提出

2026年5月2日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月19日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • HLP1-1331

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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