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

NCT07645209 | Active Not Recruiting

• 1 other identifier: HLJ-HCC-RWS-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

Real-World Study; Immunotherapy; Retrospective Study

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  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.

Secondary Outcomes (6)

• Real-World Progression-Free Survival (rwPFS)

  From start of treatment to progression or death, assessed up to 36 months.

• Real-World Objective Response Rate (rwORR)

  From start of treatment to end of treatment, assessed up to 36 months.

• Real-World Best Overall Response (rwBOR)

  From start of treatment to end of treatment, assessed up to 36 months.

• Real-World Disease Control Rate (rwDCR)

  From start of treatment to end of treatment, assessed up to 36 months

• Real-World Duration of Response (rwDOR)

  From first response to progression or death, assessed up to 36 months.

Study Arms (4)

Perioperative Therapy Cohort

Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment.

Drug: Immune Checkpoint Inhibitors

Locoregional Therapy Combined Cohort

Patients receiving immune-based combination therapy combined with locoregional therapies such as ablation, TACE, HAIC, or radiotherapy.

Drug: Immune Checkpoint Inhibitors

First-Line Advanced Cohort

Patients with advanced HCC who have received no prior systemic therapy and receive immune-based combination as first-line treatment.

Drug: Immune Checkpoint Inhibitors

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.

Drug: Immune Checkpoint Inhibitors

Interventions

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

First-Line Advanced Cohort; Later-Line Advanced Cohort; Locoregional Therapy Combined Cohort; Perioperative Therapy Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Harbin, Heilongjiang, 150081, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): May 13, 2028
• Study Completion (Estimated): May 13, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)