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A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions

8. června 2026 aktualizováno: Yingjian Liang, Harbin Medical University
Hepatocellular carcinoma (HCC) is a common global malignancy. In China, the disease burden is substantial: HCC ranks fifth in cancer incidence and third in mortality, with a 5-year relative survival of only 14.4%. In Northeast China's cold regions, metabolic diseases such as hypertension, hyperlipidemia, and diabetes are prevalent and may influence HCC prognosis. Recently, PD-1/PD-L1 inhibitor-based combination regimens (with targeted therapy, chemotherapy, or locoregional treatment) have achieved major breakthroughs, significantly extending overall and progression-free survival. These regimens have become the first-line backbone for unresectable HCC. Investigating their real-world effectiveness and safety is critical for optimizing regional treatment strategies.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

This open-label, multicenter, retrospective real-world study aims to enroll 1000 patients with confirmed HCC, intrahepatic cholangiocarcinoma, or mixed cell carcinoma who have long-term residence in Northeast China (annual mean temperature 1.6°C-10°C) and have received immune-based combination therapy. Patient data will be retrospectively collected from January 1, 2020, to December 31, 2025. Based on treatment stage, patients will be assigned to 1 of 4 cohorts: perioperative (neoadjuvant/adjuvant), locoregional therapy, first-line advanced, or later-line advanced. This noninterventional study does not alter routine clinical practice; data are derived from medical records. The primary objective is to evaluate real-world effectiveness and safety of immune-based combinations. The primary endpoint is overall survival (OS). Secondary endpoints include objective response rate (rwORR), progression-free survival (rwPFS), disease control rate (rwDCR), duration of response (rwDOR), and safety (AE, SAE, irAE rates). The findings aim to provide real-world evidence for immunotherapy in HCC across Northeast China.

Typ studie

Pozorovací

Zápis (Odhadovaný)

1000

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Heilongjiang
      • Harbin, Heilongjiang, Čína, 150081
        • Harbin Medical University Cancer Hospital, No. 150 Haping Road, Nangang District, Harbin, Heilongjiang Province, China

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Patients with a clinically confirmed diagnosis of primary hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA), or combined hepatocellular-cholangiocarcinoma (cHCC-CCA), with measurable tumor lesions.

Popis

Inclusion Criteria

  1. Patients with a clinically confirmed diagnosis of primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or combined hepatocellular-cholangiocarcinoma, with measurable tumor lesions.
  2. Patients who have long-term residence in the cold regions of Northeast China, specifically in provinces with an annual mean temperature between 1.6°C and 10°C: Heilongjiang Province, Jilin Province, and selected cities in Liaoning Province.
  3. Patients who have received an immune-based therapy regimen.
  4. Patients with complete clinical data who meet the enrollment criteria, retrospectively collected from January 1, 2020, to December 31, 2025.

Exclusion Criteria

  1. Patients with concurrent other malignancies.
  2. Patients who are confirmed pregnant or breastfeeding.
  3. Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Perioperative Therapy Cohort
Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment.
Lék: Immune Checkpoint Inhibitors

Immunotherapy:

PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors.

Targeted therapy:

Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents.

Chemotherapy:

Oxaliplatin-based and other systemic chemotherapy regimens.

Locoregional therapy:

Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy.

Other regimens selected/recommended by investigators:

Including but not limited to traditional Chinese medicine preparations and other antitumor therapies.

Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera
Locoregional Therapy Combined Cohort
Patients receiving immune-based combination therapy combined with locoregional therapies such as ablation, TACE, HAIC, or radiotherapy.
Lék: Immune Checkpoint Inhibitors

Immunotherapy:

PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors.

Targeted therapy:

Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents.

Chemotherapy:

Oxaliplatin-based and other systemic chemotherapy regimens.

Locoregional therapy:

Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy.

Other regimens selected/recommended by investigators:

Including but not limited to traditional Chinese medicine preparations and other antitumor therapies.

Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera
First-Line Advanced Cohort
Patients with advanced HCC who have received no prior systemic therapy and receive immune-based combination as first-line treatment.
Lék: Immune Checkpoint Inhibitors

Immunotherapy:

PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors.

Targeted therapy:

Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents.

Chemotherapy:

Oxaliplatin-based and other systemic chemotherapy regimens.

Locoregional therapy:

Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy.

Other regimens selected/recommended by investigators:

Including but not limited to traditional Chinese medicine preparations and other antitumor therapies.

Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera
Later-Line Advanced Cohort
Patients with advanced HCC who have progressed after at least one prior systemic therapy and receive immune-based combination as subsequent treatment.
Lék: Immune Checkpoint Inhibitors

Immunotherapy:

PD-1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) and other immune checkpoint inhibitors; PD-L1 inhibitors (e.g., atezolizumab, durvalumab, adebrelimab) and other immune checkpoint inhibitors.

Targeted therapy:

Lenvatinib, donafenib, sorafenib, apatinib, bevacizumab, and other targeted therapy agents.

Chemotherapy:

Oxaliplatin-based and other systemic chemotherapy regimens.

Locoregional therapy:

Transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiofrequency ablation (RFA), microwave ablation (MWA), percutaneous ethanol injection (PEI), cryoablation, external beam radiotherapy (EBRT), and internal radiotherapy.

Other regimens selected/recommended by investigators:

Including but not limited to traditional Chinese medicine preparations and other antitumor therapies.

Treatment options include immunotherapy alone, immunotherapy combined with targeted therapy, or immunotherapy combined with locoregional thera

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival
Časové okno: From start of treatment to death or last follow-up, assessed up to 36 months.
Time from initiation of immune-based combination therapy to death from any cause
From start of treatment to death or last follow-up, assessed up to 36 months.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Real-World Progression-Free Survival (rwPFS)
Časové okno: From start of treatment to progression or death, assessed up to 36 months.
Time from treatment initiation to first documented disease progression or death, based on real-world clinical assessment.
From start of treatment to progression or death, assessed up to 36 months.
Real-World Objective Response Rate (rwORR)
Časové okno: From start of treatment to end of treatment, assessed up to 36 months.
Proportion of patients with best overall response of complete response (CR) or partial response (PR) based on real-world clinical assessment.
From start of treatment to end of treatment, assessed up to 36 months.
Real-World Best Overall Response (rwBOR)
Časové okno: From start of treatment to end of treatment, assessed up to 36 months.
Best tumor response recorded during treatment, including CR, PR, SD, PD, or NE based on real-world clinical assessment.
From start of treatment to end of treatment, assessed up to 36 months.
Real-World Disease Control Rate (rwDCR)
Časové okno: From start of treatment to end of treatment, assessed up to 36 months
Proportion of patients with best overall response of CR, PR, or stable disease (SD) based on real-world clinical assessment.
From start of treatment to end of treatment, assessed up to 36 months
Real-World Duration of Response (rwDOR)
Časové okno: From first response to progression or death, assessed up to 36 months.
Time from first documented CR or PR to disease progression or death, assessed in patients who achieved objective response.
From first response to progression or death, assessed up to 36 months.
AE Incidence
Časové okno: From first dose to 90 days after last dose of immunotherapy or 30 days after last dose of antiangiogenic agents, whichever is later.
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), graded by NCI-CTCAE v6.0.
From first dose to 90 days after last dose of immunotherapy or 30 days after last dose of antiangiogenic agents, whichever is later.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Harbin Medical University

Spolupracovníci

The Second Affiliated Hospital of Harbin Medical University
China-Japan Union Hospital, Jilin University
First Affiliated Hospital of Harbin Medical University
Liaoning Cancer Hospital & Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. května 2026

Primární dokončení (Odhadovaný)

13. května 2028

Dokončení studie (Odhadovaný)

13. května 2029

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

8. června 2026

První zveřejněno (Aktuální)

12. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HLJ-HCC-RWS-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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