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

19. Mai 2026 aktualisiert von: 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)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

166

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Henan
      • Kaifeng, Henan, China
        • Huaihe Hospital of Henan University
        • Kontakt:
        • Hauptermittler:
          • Li Zexin, doctor's degree
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
        • Kontakt:
          • Wang Kai, Doctor
          • Telefonnummer: +86 13767104812
          • E-Mail: neswk@163.com
        • Hauptermittler:
          • Wang Kai, doctor's degree
    • Zhejiang Provinece
      • Hangzhou, Zhejiang Provinece, China
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
        • Hauptermittler:
          • Liang Tingbo, doctor's degree
      • Yiwu, Zhejiang Provinece, China
        • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Tang Zhe, Doctor
          • Telefonnummer: +86 18867961022
          • E-Mail: 8xi@zju.edu.cn
        • Hauptermittler:
          • Tang Zhe, doctor's degree

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental group
Multimodal Thermal Therapy Combined with Targeted and Immune Drugs
Gerät: 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.
Arzneimittel: 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.
Aktiver Komparator: Control Group
Targeted and Immune Drugs
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free survival (PFS) per mRECIST
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Response Rate (ORR) per mRECIST
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Zhejiang University

Ermittler

  • Hauptermittler: Liang Tingbo, doctor's degree, Zhejiang University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

25. Mai 2026

Primärer Abschluss (Geschätzt)

25. Mai 2028

Studienabschluss (Geschätzt)

25. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

2. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • HLP1-1331

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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