Unresectable Liver CancerNCT06715072
Study on the Efficacy and Safety of Transarterial Chemoembolization Combined With Targeted Immunotherapy in Patients With Unresectable Hepatocellular Carcinoma
An observational study of Unresectable Liver Cancer, run by Yao Xie.
Trial summary
This study is a single-center, single-arm, prospective study. It enrolls patients with unresectable hepatocellular carcinoma (HCC). The study aims to investigate the efficacy and safety of transarterial chemoembolization combined with targeted immunotherapy in patients with unresectable HCC, providing treatment… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Unresectable Liver Cancer
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Dec 2026
- 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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unresectable Liver Cancer
Inclusion Criteria:Voluntarily join this study and sign the informed consent form;Age ≥18 years and ≤68 years, receiving arterial chemoembolization combined with targeted immunotherapy, regardless of gender;At least one measurable lesion as defined by the Modified Response Evaluation Criteria in Solid Tumors (mRECIST);Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1;Child-Pugh score ≤7;Generally good condition, such as albumin >25 g/L, white blood cells >3×10^9/L (excluding causes such as hypersplenism), platelets >50×10^9/L, etc.;Expected survival >12 weeks;No fertility requirements.
Exclusion Criteria:Uncontrolled hypertension;Active autoimmune diseases;Concurrent other untreated malignancies;Pregnant or breastfeeding women;Active bleeding tendency or coagulation disorders;Severe liver, kidney, heart, or bone marrow dysfunction;Severe allergy to iodine contrast agents;Other contraindications to the use of TACE, lenvatinib, camrelizumab, atezolizumab, bevacizumab, etc.;The investigator believes that accompanying medical history may affect the subject's safe completion of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single-center, single-arm, prospective study. It enrolls patients with unresectable hepatocellular carcinoma (HCC). The study aims to investigate the efficacy and safety of transarterial chemoembolization combined with targeted immunotherapy in patients with unresectable HCC, providing treatment guidance for these patients.
Read the detailed description
Primary liver cancer (PLC) represents the sixth most common cancer and the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) accounts for 75% to 85% of PLC cases, with the main etiologies being hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Approximately 44-62% of HCC patients develop portal vein tumor thrombus (PVTT), which plays a major role in disease prognosis. These patients have a poor prognosis, with a median survival time of 2.7-4 months without any intervention, posing a significant challenge to clinicians. Both the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines recommend that HCC patients with PVTT be classified as Barcelona Clinic Liver Cancer stage C (BCLC-C) and receive systemic therapy.For unresectable HCC, trans-arterial chemoembolization (TACE) is one of the most commonly used techniques and can significantly improve survival rates. Compared to best supportive care, TACE can significantly extend the overall survival (OS) of PVTT type I-III HCC by nearly 3 months . Sorafenib, a tyrosine kinase inhibitor (TKI), is the first approved targeted drug and has shown some survival benefits in advanced HCC compared to placebo. The REFLECT trial demonstrated that lenvatinib improved time to progression (TTP) and objective response rate (ORR) compared to sorafenib [13]. Two other studies also confirmed that TACE combined with lenvatinib had significantly better clinical efficacy in HCC with PVTT compared to TACE combined with sorafenib.Increasing evidence suggests that immune checkpoint inhibitors (ICIs) combined with multi-kinase TKIs or vascular endothelial growth factor (VEGF) antibodies are becoming a trend in the treatment of advanced HCC. Moreover, the inflammatory factors produced and released during TACE treatment have a priming effect on adaptive immunity; TACE can induce spontaneous T-cell responses and modulate the tumor microenvironment. The combined use of TACE and ICIs may more effectively promote antitumor immune reconstitution. A retrospective study reported that TACE combined with camrelizumab and apatinib significantly improved OS in HCC, with an ORR superior to the dual regimen of apatinib and camrelizumab. Another retrospective study involving 22 patients with advanced HCC showed that using lenvatinib and camrelizumab with TACE could control tumor progression and extend survival. However, data on this triple regimen for treating unresectable hepatocellular carcinoma are limited. Therefore, this study will provide evidence for the triple regimen in treating unresectable hepatocellular carcinoma.
- Conditions
- Unresectable Liver Cancer
- Keywords
- Unresectable Liver Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Evaluation
The time from the date of the first dose of lenvatinib to disease progression or death from any cause.
Measured: tree years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study startJul 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Unresectable 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yao Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yao Xie, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715072
- Sponsor's protocol ID
- DTXY30
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li M, Hao J, Jiang T, Deng W, Lu H, Wang S, Wan G, Xie Y, Yi W. Maternal and neonatal safety of COVID-19 vaccination during the peri-pregnancy period: A prospective study. J Med Virol. 2023 Jan;95(1):e28378. doi: 10.1002/jmv.28378.
PubMed 36478410
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Transarterial Chemoembolization Combined With Targeted Immunotherapy in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06715072
- Acronym / sponsor ID
- DTXY30
- Conditions
- Unresectable Liver Cancer
- Keywords
- Unresectable Liver Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yao XieUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Dec 2024 (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 is a single-center, single-arm, prospective study. It enrolls patients with unresectable hepatocellular carcinoma (HCC). The study aims to investigate the efficacy and safety of transarterial chemoembolization combined with targeted immunotherapy in patients with unresectable HCC, providing treatment guidance for these patients.
Detailed description
Primary liver cancer (PLC) represents the sixth most common cancer and the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) accounts for 75% to 85% of PLC cases, with the main etiologies being hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Approximately 44-62% of HCC patients develop portal vein tumor thrombus (PVTT), which plays a major role in disease prognosis. These patients have a poor prognosis, with a median survival time of 2.7-4 months without any intervention, posing a significant challenge to clinicians. Both the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) guidelines recommend that HCC patients with PVTT be classified as Barcelona Clinic Liver Cancer stage C (BCLC-C) and receive systemic therapy.For unresectable HCC, trans-arterial chemoembolization (TACE) is one of the most commonly used techniques and can significantly improve survival rates. Compared to best supportive care, TACE can significantly extend the overall survival (OS) of PVTT type I-III HCC by nearly 3 months . Sorafenib, a tyrosine kinase inhibitor (TKI), is the first approved targeted drug and has shown some survival benefits in advanced HCC compared to placebo. The REFLECT trial demonstrated that lenvatinib improved time to progression (TTP) and objective response rate (ORR) compared to sorafenib [13]. Two other studies also confirmed that TACE combined with lenvatinib had significantly better clinical efficacy in HCC with PVTT compared to TACE combined with sorafenib.Increasing evidence suggests that immune checkpoint inhibitors (ICIs) combined with multi-kinase TKIs or vascular endothelial growth factor (VEGF) antibodies are becoming a trend in the treatment of advanced HCC. Moreover, the inflammatory factors produced and released during TACE treatment have a priming effect on adaptive immunity; TACE can induce spontaneous T-cell responses and modulate the tumor microenvironment. The combined use of TACE and ICIs may more effectively promote antitumor immune reconstitution. A retrospective study reported that TACE combined with camrelizumab and apatinib significantly improved OS in HCC, with an ORR superior to the dual regimen of apatinib and camrelizumab. Another retrospective study involving 22 patients with advanced HCC showed that using lenvatinib and camrelizumab with TACE could control tumor progression and extend survival. However, data on this triple regimen for treating unresectable hepatocellular carcinoma are limited. Therefore, this study will provide evidence for the triple regimen in treating unresectable hepatocellular carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable Liver Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy Evaluation
Time frame: tree years
The time from the date of the first dose of lenvatinib to disease progression or death from any cause.
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 4 Dec 2024.
- Results publication: PubMed 36478410Li M, Hao J, Jiang T, Deng W, Lu H, Wang S, Wan G, Xie Y, Yi W. Maternal and neonatal safety of COVID-19 vaccination during the peri-pregnancy period: A prospective study. J Med Virol. 2023 Jan;95(1):e28378. doi: 10.1002/jmv.28378.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Liver Cancer, run by Yao Xie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yao Xie (86+13501093293, wuhm2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Evaluation (time frame: tree years). 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 NCT06715072, 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 4 Dec 2024.