Hepatocellular CarcinomaNCT05635279
Effect of Nutritional Indices on the Prognosis of HCC Patients
An observational study of Hepatocellular Carcinoma, run by Juan Kang at 1 site in China.
Trial summary
Primary liver cancer has recently ranked among the leading causes of cancer death, with hepatocellular carcinoma (HCC) accounting for 75%-85% of these cases. In recent years, immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) have achieved good results in the treatment of advanced HCC… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 9 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.
Who may be able to join
- Cohort 1:HCC patients received ICIs combined with TKIs regularly and periodically.
- Cohort 2:HCC patients who underwent TACE as initial treatment.
Who cannot join
- Patients with systemic malignant tumors other than HCC.
- Patients with severe hypertension, diabetes, coronary heart disease, systemic infection and other serious diseases.
- patients with immunodeficiency or autoimmune diseases.
- Patients with severe malnutrition.
- Not adhering to regular and periodic treatment.
- Patients without regular follow-up or with missing data to be collected.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Study on the Effect of Nutritional Indices on the Prognosis of Hepatocellular Carcinoma Patients
Primary liver cancer has recently ranked among the leading causes of cancer death, with hepatocellular carcinoma (HCC) accounting for 75%-85% of these cases. In recent years, immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) have achieved good results in the treatment of advanced HCC patients. So far, there is a lack of studies exploring the relationship between nutritional index and the prognosis of HCC patients treated with ICIs combined with TKIs, and there are few studies on the prognostic value of nutritional index in HCC patients treated with transarterial chemoembolization (TACE). This retrospective study aims to analyze the prognostic value of prognostic nutritional index(PNI)，body mass index (BMI), psoas muscle index（PMI）and geriatric nutritional risk index (GNRI) in HCC patients who received ICIs combined with TKIs or TACE, and to provide reference for the selection of nutritional intervention programs for HCC patients.
Read the detailed description
Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.The data needed to be collected included age, gender, height and weight at initial treatment and regular follow-up. Blood routine, liver function, kidney function, coagulation function, electrolytes, PIVKA-II, AFP, HBV-DNA, CT, MRI information, China liver cancer staging (CNLC), complications, treatment plan, etc. Follow-up time after initiation of treatment and time of death or significant disease progression. The survival was estimated by the Kaplan-Meier method and curves were compared by the log-rank test.Logistic regression was used to univariate and multivariate analyze the effect of variables on the outcome. Variables with P<0.05 on a univariate analysis were subjected to a multivariate analysis.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- prognostic nutritional index, psoas muscle index, geriatric nutritional risk index, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| HCC patients who received ICIs combined with TKIs | HCC patients who received ICIs combined with TKIs regularly and periodically. | |
| HCC patients treated with TACE | HCC patients who underwent TACE as initial treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death due to hepatocellular carcinoma progression
Measured: November 2022 to May 2024
Secondary outcomes (1)
Censored
Death due to other causes such as car accidents or loss to follow-up
Measured: November 2022 to May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Nov 2022
- Primary completion7 Jan 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Kang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Kang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Juan Kang, M.D., Study chair, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635279
- Sponsor's protocol ID
- 2022-182
- Status last verified
- Jun 2025
- First submitted
- 22 Nov 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo N, Li H, Luo Y, Hu P, Liang L, Zhang R, Zhang D, Cai D, Kang J. Prognostic significance of psoas muscle index in male hepatocellular carcinoma patients treated with immune checkpoint inhibitors and tyrosine kinase inhibitors. Hum Vaccin Immunother. 2023 Aug;19(2):2258567. doi: 10.1080/21645515.2023.2258567. Epub 2023 Sep 20.
PubMed 37728115
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Nutritional Indices on the Prognosis of Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05635279
- Acronym / sponsor ID
- 2022-182
- Conditions
- Hepatocellular Carcinoma
- Keywords
- prognostic nutritional index, psoas muscle index, geriatric nutritional risk index, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Juan KangUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 7 Jan 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 2 Dec 2022 (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.
Primary liver cancer has recently ranked among the leading causes of cancer death, with hepatocellular carcinoma (HCC) accounting for 75%-85% of these cases. In recent years, immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) have achieved good results in the treatment of advanced HCC patients. So far, there is a lack of studies exploring the relationship between nutritional index and the prognosis of HCC patients treated with ICIs combined with TKIs, and there are few studies on the prognostic value of nutritional index in HCC patients treated with transarterial chemoembolization (TACE). This retrospective study aims to analyze the prognostic value of prognostic nutritional index(PNI)，body mass index (BMI), psoas muscle index（PMI）and geriatric nutritional risk index (GNRI) in HCC patients who received ICIs combined with TKIs or TACE, and to provide reference for the selection of nutritional intervention programs for HCC patients.
Detailed description
Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.The data needed to be collected included age, gender, height and weight at initial treatment and regular follow-up. Blood routine, liver function, kidney function, coagulation function, electrolytes, PIVKA-II, AFP, HBV-DNA, CT, MRI information, China liver cancer staging (CNLC), complications, treatment plan, etc. Follow-up time after initiation of treatment and time of death or significant disease progression. The survival was estimated by the Kaplan-Meier method and curves were compared by the log-rank test.Logistic regression was used to univariate and multivariate analyze the effect of variables on the outcome. Variables with P<0.05 on a univariate analysis were subjected to a multivariate analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCC patients who received ICIs combined with TKIs | – | –HCC patients who received ICIs combined with TKIs regularly and periodically. |
| HCC patients treated with TACE | – | –HCC patients who underwent TACE as initial treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who confirmed HCC in the Second Affiliated Hospital of Chongqing Medical University were enrolled in the retrospective study. The subjects were divided into two cohorts, both of which met the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Cohort 1:HCC patients received ICIs combined with TKIs regularly and periodically.
- Cohort 2:HCC patients who underwent TACE as initial treatment.
Key exclusion criteria (6 listed)
- Patients with systemic malignant tumors other than HCC.
- Patients with severe hypertension, diabetes, coronary heart disease, systemic infection and other serious diseases.
- patients with immunodeficiency or autoimmune diseases.
- Patients with severe malnutrition.
- Not adhering to regular and periodic treatment.
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 |
|---|---|---|
| Other | HCC patients treated with TACE, HCC patients who received ICIs combined with TKIs |
Primary outcome
Death
Time frame: November 2022 to May 2024
Death due to hepatocellular carcinoma progression
1 secondary outcome
Censored
Time frame: November 2022 to May 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 37728115Luo N, Li H, Luo Y, Hu P, Liang L, Zhang R, Zhang D, Cai D, Kang J. Prognostic significance of psoas muscle index in male hepatocellular carcinoma patients treated with immune checkpoint inhibitors and tyrosine kinase inhibitors. Hum Vaccin Immunother. 2023 Aug;19(2):2258567. doi: 10.1080/21645515.2023.2258567. Epub 2023 Sep 20.
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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.
Juan Kang, M.D. study chair
The Second Affiliated Hospital of Chongqing Medical University
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 Hepatocellular Carcinoma, run by Juan Kang 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: November 2022 to May 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635279, which also lists 1 linked publication.
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 25 Jun 2025.