HCC - Hepatocellular CarcinomaNCT06991907
PD-1 Inhibitor Combined With 125I Seed Implantation for Hepatocellular Carcinoma's Extrahepatic Metastasis: Efficacy and Safety
A study testing 125I seed implantation and PD-1 Inhibitors in people with HCC - Hepatocellular Carcinoma and 125I Seeds Implantation, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study aims to explore the effectiveness and safety of 125I seed implantation in the treatment of hepatocellular carcinoma (HCC) with extrahepatic metastases, and to compare the efficacy differences between PD-1 inhibitor monotherapy and the combination of PD-1 inhibitor and 125I seed implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, 125I Seeds Implantation
- What is being tested?
- 125I seed implantation and PD-1 Inhibitors
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 20 Mar 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Diagnosis of advanced primary hepatocellular carcinoma (HCC) according to established criteria [13]; (2) Presence of ≥1 measurable extrahepatic metastatic lesions; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0; (4) Barcelona Clinic Liver Cancer (BCLC) stage C; (5) Child-Pugh class A or B; (6) Platelet count > 75×10⁹/L; (7) Estimated life expectancy > 3 months; (8) Complete clinical data available.
Who cannot join
- (1) Poor treatment compliance or inability to cooperate with ¹²⁵I seed implantation surgery; (2) Unavoidable large bronchi or major blood vessels along the puncture pathway for seed implantation; (3) History of other primary malignant tumors (except cured non-melanoma skin cancer or in-situ carcinomas); (4) Severe cardiorenal insufficiency (e.g., New York Heart Association class III/IV heart failure or estimated glomerular filtration rate < 30 mL/min/1.73m²); (5) Incomplete clinical data or loss to follow-up before the study endpoint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of PD-1 Inhibitor Combined With 125I Seed Implantation in the Treatment of Extrahepatic Metastasis of Hepatocellular Carcinoma
This study aims to explore the effectiveness and safety of 125I seed implantation in the treatment of hepatocellular carcinoma (HCC) with extrahepatic metastases, and to compare the efficacy differences between PD-1 inhibitor monotherapy and the combination of PD-1 inhibitor and 125I seed implantation.
A retrospective analysis was conducted on 80 eligible patients admitted to Jiangxi Provincial Cancer Hospital from January 2018 to March 2025, with 40 patients in each group. Data including patients' basic characteristics, tumor staging, alpha-fetoprotein (AFP) levels, history of hepatitis B virus (HBV) infection, etc., were collected. Parameters of seed implantation and details of metastatic lesions were recorded.
Through regular follow-ups after treatment, the degree of pain relief (evaluated by Visual Analogue Scale, VAS), tumor control efficacy (response rate, RR; local control rate, LCR), survival outcomes (local progression-free survival, LPFS; progression-free survival, PFS; overall survival, OS) were assessed. Additionally, indicators such as blood cell analysis, liver and kidney function, and treatment-related adverse reactions were monitored, providing a clinical basis for optimizing comprehensive treatment regimens for HCC with extrahepatic metastases.
- Being tested
- 125I seed implantation, PD-1 Inhibitors
- Keywords
- Hepatocellular Carcinoma, 125I Seed Implantation, PD-1 Inhibitors, Efficacy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
125I seed implantationProcedure or surgery
125I seed implantation
PD-1 InhibitorsDrug
PD-1 inhibitors (sintilimab/teriprizumab/camrelizumab) are administered intravenously at a dose of 200 mg once every three weeks. According to the manufacturer's guidelines, the dose is reduced or discontinued based on the severity of adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 inhibitor combined with 125I seed implantation group (combination therapy group) | Active comparator | The combination therapy group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy (selected based on individual patient assessment and shared decision-making) alongside 125I radioactive seed implantation targeting their extrahepatic metastatic lesions. The intervention involves percutaneous implantation of 125I seeds into accessible metastases under imaging guidance to deliver localized radiation, complemented by systemic PD-1 inhibitor administration according to standard protocols. Patients undergo regular follow-ups to monitor treatment response (e.g., tumor size, pain scores), assess safety through laboratory and imaging evaluations, and manage comorbidities (such as hepatitis B virus infection or treatment-related adverse events) to ensure personalized, comprehensive care throughout the treatment course. Receives: Procedure: 125I seed implantation; Drug: PD-1 Inhibitors |
| PD-1 inhibitor monotherapy group (PD-1 single-agent group) | Sham comparator | The PD-1 single-agent group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy selected through shared decision-making based on their individual clinical status, tumor characteristics, and treatment preferences. The intervention involves systemic administration of PD-1 inhibitors (e.g., pembrolizumab, nivolumab) according to standard oncological protocols, with dose and treatment schedule tailored to guidelines and patient tolerance. Patients in this group undergo regular follow-ups to assess treatment response (e.g., tumor progression via imaging, serum AFP levels), monitor safety through laboratory evaluations (blood counts, liver/kidney function), and manage comorbidities-such as chronic hepatitis B virus infection requiring antiviral prophylaxis or immune-related adverse events (e.g., pneumonitis, colitis)-to ensure safe and effective care throughout the treatment course. Receives: Drug: PD-1 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression - free Survival (PFS)
It is the time interval from the start of treatment (initiation of PD - 1 inhibitor therapy or combination treatment) to the occurrence of tumor progression (defined by imaging criteria such as RECIST) or death from any cause, whichever comes first. Tumor progression includes the development of new lesions, increase in the size of existing lesions, or clinical deterioration indicative of disease advancement.
Measured: Eligible patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow-up was measured from treatment start to first progression/death, with survival cutoff in Apr 2025 (max 62 months).
Secondary outcomes (1)
Overall Survival
The length of time from either the start of treatment or diagnosis until the death of the patient from any cause.
Measured: Patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow - up measured from treatment start to death, with survival cutoff in Apr 2025 (max 62 months）.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2020
- Primary completion19 Mar 2025
- Study completion20 Mar 2025
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 HCC - 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991907
- Sponsor's protocol ID
- 2025ky159
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang X, Liu Y, Chen L, Tan L, Wei X, Chen Z. The efficacy and safety of PD-1 inhibitors combined with 125I seed implantation in treating extrahepatic metastasis of hepatocellular carcinoma. Front Med (Lausanne). 2025 Nov 20;12:1693447. doi: 10.3389/fmed.2025.1693447. eCollection 2025.
PubMed 41357510
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-1 Inhibitor Combined With 125I Seed Implantation in the Treatment of Extrahepatic Metastasis of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06991907
- Acronym / sponsor ID
- 2025ky159
- Keywords
- Hepatocellular Carcinoma, 125I Seed Implantation, PD-1 Inhibitors, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 28 May 2025 (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.
This study aims to explore the effectiveness and safety of 125I seed implantation in the treatment of hepatocellular carcinoma (HCC) with extrahepatic metastases, and to compare the efficacy differences between PD-1 inhibitor monotherapy and the combination of PD-1 inhibitor and 125I seed implantation.
A retrospective analysis was conducted on 80 eligible patients admitted to Jiangxi Provincial Cancer Hospital from January 2018 to March 2025, with 40 patients in each group. Data including patients' basic characteristics, tumor staging, alpha-fetoprotein (AFP) levels, history of hepatitis B virus (HBV) infection, etc., were collected. Parameters of seed implantation and details of metastatic lesions were recorded.
Through regular follow-ups after treatment, the degree of pain relief (evaluated by Visual Analogue Scale, VAS), tumor control efficacy (response rate, RR; local control rate, LCR), survival outcomes (local progression-free survival, LPFS; progression-free survival, PFS; overall survival, OS) were assessed. Additionally, indicators such as blood cell analysis, liver and kidney function, and treatment-related adverse reactions were monitored, providing a clinical basis for optimizing comprehensive treatment regimens for HCC with extrahepatic metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 inhibitor combined with 125I seed implantation group (combination therapy group) | Active comparator | Procedure: 125I seed implantation, Drug: PD-1 InhibitorsThe combination therapy group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy (selected based on individual patient assessment and shared decision-making) alongside 125I radioactive seed implantation targeting their extrahepatic metastatic lesions. The intervention involves percutaneous implantation of 125I seeds into accessible metastases under imaging guidance to deliver localized radiation, complemented by systemic PD-1 inhibitor administration according to standard protocols. Patients undergo regular follow-ups to monitor treatment response (e.g., tumor size, pain scores), assess safety through laboratory and imaging evaluations, and manage comorbidities (such as hepatitis B virus infection or treatment-related adverse events) to ensure personalized, comprehensive care throughout the treatment course. |
| PD-1 inhibitor monotherapy group (PD-1 single-agent group) | Sham comparator | Drug: PD-1 InhibitorsThe PD-1 single-agent group includes patients with hepatocellular carcinoma and extrahepatic metastases who receive PD-1 inhibitor therapy selected through shared decision-making based on their individual clinical status, tumor characteristics, and treatment preferences. The intervention involves systemic administration of PD-1 inhibitors (e.g., pembrolizumab, nivolumab) according to standard oncological protocols, with dose and treatment schedule tailored to guidelines and patient tolerance. Patients in this group undergo regular follow-ups to assess treatment response (e.g., tumor progression via imaging, serum AFP levels), monitor safety through laboratory evaluations (blood counts, liver/kidney function), and manage comorbidities-such as chronic hepatitis B virus infection requiring antiviral prophylaxis or immune-related adverse events (e.g., pneumonitis, colitis)-to ensure safe and effective care throughout the treatment course. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Diagnosis of advanced primary hepatocellular carcinoma (HCC) according to established criteria [13]; (2) Presence of ≥1 measurable extrahepatic metastatic lesions; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0; (4) Barcelona Clinic Liver Cancer (BCLC) stage C; (5) Child-Pugh class A or B; (6) Platelet count > 75×10⁹/L; (7) Estimated life expectancy > 3 months; (8) Complete clinical data available.
Key exclusion criteria (1 listed)
- (1) Poor treatment compliance or inability to cooperate with ¹²⁵I seed implantation surgery; (2) Unavoidable large bronchi or major blood vessels along the puncture pathway for seed implantation; (3) History of other primary malignant tumors (except cured non-melanoma skin cancer or in-situ carcinomas); (4) Severe cardiorenal insufficiency (e.g., New York Heart Association class III/IV heart failure or estimated glomerular filtration rate < 30 mL/min/1.73m²); (5) Incomplete clinical data or loss to follow-up before the study endpoint.
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 |
|---|---|---|
| 125I seed implantation125I seed implantation | Procedure or surgery | PD-1 inhibitor combined with 125I seed implantation group (combination therapy group) |
| PD-1 InhibitorsPD-1 inhibitors (sintilimab/teriprizumab/camrelizumab) are administered intravenously at a dose of 200 mg once every three weeks. According to the manufacturer's guidelines, the dose is reduced or discontinued based on the severity of adverse effects. | Drug | PD-1 inhibitor combined with 125I seed implantation group (combination therapy group), PD-1 inhibitor monotherapy group (PD-1 single-agent group) |
Primary outcome
Progression - free Survival (PFS)
Time frame: Eligible patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow-up was measured from treatment start to first progression/death, with survival cutoff in Apr 2025 (max 62 months).
It is the time interval from the start of treatment (initiation of PD - 1 inhibitor therapy or combination treatment) to the occurrence of tumor progression (defined by imaging criteria such as RECIST) or death from any cause, whichever comes first. Tumor progression includes the development of new lesions, increase in the size of existing lesions, or clinical deterioration indicative of disease advancement.
1 secondary outcome
Overall Survival
Time frame: Patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow - up measured from treatment start to death, with survival cutoff in Apr 2025 (max 62 months）.
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 28 May 2025.
- Derived from this study: PubMed 41357510Tang X, Liu Y, Chen L, Tan L, Wei X, Chen Z. The efficacy and safety of PD-1 inhibitors combined with 125I seed implantation in treating extrahepatic metastasis of hepatocellular carcinoma. Front Med (Lausanne). 2025 Nov 20;12:1693447. doi: 10.3389/fmed.2025.1693447. eCollection 2025.
- 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?
A study testing 125I seed implantation and PD-1 Inhibitors in people with HCC - Hepatocellular Carcinoma and 125I Seeds Implantation, run by Jiangxi Provincial Cancer Hospital 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 1 inclusion and 1 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 28 May 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. Some participants in this study may receive a placebo. 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?
Progression - free Survival (PFS) (time frame: Eligible patients who received assigned study treatment (monotherapy/combination) between Jan 2020 and Mar 2025 were enrolled. Follow-up was measured from treatment start to first progression/death, with survival cutoff in Apr 2025 (max 62 months).). 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 NCT06991907, 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 28 May 2025.