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NCT Number: NCT07645209

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Harbin, Heilongjiang, 150081, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a clinically confirmed diagnosis of primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or combined hepatocellular-cholangiocarcinoma, with measurable tumor lesions.
  • 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.
  • Patients who have received an immune-based therapy regimen.
  • Patients with complete clinical data who meet the enrollment criteria, retrospectively collected from January 1, 2020, to December 31, 2025.

Exclusion criteria

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

Treatment and study plan

Immune Checkpoint Inhibitors

Drug

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

Primary outcomes

  1. Overall Survival

    Time frame: 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

Secondary outcomes

  1. Real-World Progression-Free Survival (rwPFS)

    Time frame: 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.

  2. Real-World Objective Response Rate (rwORR)

    Time frame: 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.

  3. Real-World Best Overall Response (rwBOR)

    Time frame: 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.

  4. Real-World Disease Control Rate (rwDCR)

    Time frame: 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.

  5. Real-World Duration of Response (rwDOR)

    Time frame: 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.

  6. AE Incidence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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