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

8 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

1000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Perioperative Therapy Cohort
Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment.
Lek: 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.
Lek: 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.
Lek: 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.
Lek: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Real-World Progression-Free Survival (rwPFS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Harbin Medical University

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 maja 2026

Zakończenie podstawowe (Szacowany)

13 maja 2028

Ukończenie studiów (Szacowany)

13 maja 2029

Daty rejestracji na studia

Pierwszy przesłany

8 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • HLJ-HCC-RWS-001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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