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

8. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Perioperative Therapy Cohort
Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment.
Legemiddel: 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.
Legemiddel: 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.
Legemiddel: 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.
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Real-World Progression-Free Survival (rwPFS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Harbin Medical University

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mai 2026

Primær fullføring (Antatt)

13. mai 2028

Studiet fullført (Antatt)

13. mai 2029

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HLJ-HCC-RWS-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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