Liver CancerNCT07645209
A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
An observational study of Liver Cancer, run by Harbin Medical University at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2026to 13 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Harbin Medical University Cancer Hospital, No. 150 Haping Road, Nangang District, Harbin, Heilongjiang Province, China
Harbin, Heilongjiang, 150081
About this study
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.
Read the detailed description
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.
- Conditions
- Liver Cancer
- Being tested
- Immune Checkpoint Inhibitors
- Keywords
- Real-World Study, Immunotherapy, Retrospective Study
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint InhibitorsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Therapy Cohort | Patients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from initiation of immune-based combination therapy to death from any cause
Measured: From start of treatment to death or last follow-up, assessed up to 36 months.
Secondary outcomes (6)
Real-World Progression-Free Survival (rwPFS)
Time from treatment initiation to first documented disease progression or death, based on real-world clinical assessment.
Measured: From start of treatment to progression or death, assessed up to 36 months.
Real-World Objective Response Rate (rwORR)
Proportion of patients with best overall response of complete response (CR) or partial response (PR) based on real-world clinical assessment.
Measured: From start of treatment to end of treatment, assessed up to 36 months.
Real-World Best Overall Response (rwBOR)
Best tumor response recorded during treatment, including CR, PR, SD, PD, or NE based on real-world clinical assessment.
Measured: From start of treatment to end of treatment, assessed up to 36 months.
Real-World Disease Control Rate (rwDCR)
Proportion of patients with best overall response of CR, PR, or stable disease (SD) based on real-world clinical assessment.
Measured: From start of treatment to end of treatment, assessed up to 36 months
Real-World Duration of Response (rwDOR)
Time from first documented CR or PR to disease progression or death, assessed in patients who achieved objective response.
Measured: From first response to progression or death, assessed up to 36 months.
AE Incidence
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), graded by NCI-CTCAE v6.0.
Measured: From first dose to 90 days after last dose of immunotherapy or 30 days after last dose of antiangiogenic agents, whichever is later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start13 May 2026
- Primary completion13 May 2028 (estimated)
- Study completion13 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, China-Japan Union Hospital, Jilin University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Principal investigator, Yingjian Liang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645209
- Sponsor's protocol ID
- HLJ-HCC-RWS-001
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
- ClinicalTrials.gov ID
- NCT07645209
- Acronym / sponsor ID
- HLJ-HCC-RWS-001
- Conditions
- Liver Cancer
- Keywords
- Real-World Study, Immunotherapy, Retrospective Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, China-Japan Union Hospital, Jilin University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 13 May 2026 (actual)
- Primary completion
- 13 May 2028 (estimated)
- Study completion
- 13 May 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Perioperative Therapy Cohort | – | Drug: Immune Checkpoint InhibitorsPatients receiving immune-based combination therapy as neoadjuvant or adjuvant treatment. |
| Locoregional Therapy Combined Cohort | – | Drug: Immune Checkpoint InhibitorsPatients receiving immune-based combination therapy combined with locoregional therapies such as ablation, TACE, HAIC, or radiotherapy. |
| First-Line Advanced Cohort | – | Drug: Immune Checkpoint InhibitorsPatients with advanced HCC who have received no prior systemic therapy and receive immune-based combination as first-line treatment. |
| Later-Line Advanced Cohort | – | Drug: Immune Checkpoint InhibitorsPatients with advanced HCC who have progressed after at least one prior systemic therapy and receive immune-based combination as subsequent treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune Checkpoint InhibitorsImmunotherapy: 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 | Drug | First-Line Advanced Cohort, Later-Line Advanced Cohort, Locoregional Therapy Combined Cohort, Perioperative Therapy Cohort |
Primary outcome
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
6 secondary outcomes
Real-World Progression-Free Survival (rwPFS)
Time frame: From start of treatment to progression or death, assessed up to 36 months.
Real-World Objective Response Rate (rwORR)
Time frame: From start of treatment to end of treatment, assessed up to 36 months.
Real-World Best Overall Response (rwBOR)
Time frame: From start of treatment to end of treatment, assessed up to 36 months.
Real-World Disease Control Rate (rwDCR)
Time frame: From start of treatment to end of treatment, assessed up to 36 months
Real-World Duration of Response (rwDOR)
Time frame: From first response to progression or death, assessed up to 36 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From start of treatment to death or last follow-up, assessed up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.