Hepatocellular CarcinomaCHANCEsubNCT05278195
Assessing the Prognosis of TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for HCC by Using Clinical and Imaging Biomarkers
An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
The purpose of this study is to id transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions.
Who may be able to join
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
- 7. Has repeated measurable intrahepatic lesions according to RECIST v1.1;
Who cannot join
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Missing follow-up data;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Gao-Jun Teng, MD, +86 25 83272121, gjteng@seu.edu.cn
Hai-Dong Zhu, MD, +86-02583272121, zhuhaidong9509@163.com
About this study
Official title: Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers
The purpose of this study is to id
transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, immune checkpoint iInhibitors, transarterial chemoembolization, real-world study
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Measured: up to approximately 2 years
Secondary outcomes (4)
Specificity
The specificity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
Measured: baseline
Sensitivity
The sensitivity of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
Measured: baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence model for identifying optimal candidates among patients who treated TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapy will be calculated.
Measured: baseline
Accuracy
Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, M.D., Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278195
- Sponsor's protocol ID
- CHANCE-Biomarker
- Acronym
- CHANCEsub
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llovet JM, Villanueva A, Marrero JA, Schwartz M, Meyer T, Galle PR, Lencioni R, Greten TF, Kudo M, Mandrekar SJ, Zhu AX, Finn RS, Roberts LR; AASLD Panel of Experts on Trial Design in HCC. Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference. Hepatology. 2021 Jan;73 Suppl 1:158-191. doi: 10.1002/hep.31327. Epub 2020 Sep 9. No abstract available.
PubMed 32430997Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.
PubMed 33479224Ochoa de Olza M, Navarro Rodrigo B, Zimmermann S, Coukos G. Turning up the heat on non-immunoreactive tumours: opportunities for clinical development. Lancet Oncol. 2020 Sep;21(9):e419-e430. doi: 10.1016/S1470-2045(20)30234-5.
PubMed 32888471Pinato DJ, Murray SM, Forner A, Kaneko T, Fessas P, Toniutto P, Minguez B, Cacciato V, Avellini C, Diaz A, Boyton RJ, Altmann DM, Goldin RD, Akarca AU, Marafioti T, Mauri FA, Casagrande E, Grillo F, Giannini E, Bhoori S, Mazzaferro V. Trans-arterial chemoembolization as a loco-regional inducer of immunogenic cell death in hepatocellular carcinoma: implications for immunotherapy. J Immunother Cancer. 2021 Sep;9(9):e003311. doi: 10.1136/jitc-2021-003311.
PubMed 34593621Chen Q, Lin LW, Jin ZC, Xiong B, Hu HT, Chen JJ, Zhou GH, Zhou HF, Ding R, Zhu XL, Huang M, Shi HB, Zhao ZW, Ji JS, Yang WZ, Xu GH, Xu AB, Hu ZC, Wang WD, Zhao C, Zhu HD, Teng GJ. The METAL Score for Early Stratification of Radiological Response and Survival in Hepatocellular Carcinoma Treated with TACE and Immunotherapy Combinations. Acad Radiol. 2026 Jan;33(1):47-58. doi: 10.1016/j.acra.2025.10.027. Epub 2025 Nov 4.
PubMed 41188158Jin ZC, Zhou JW, Chen JJ, Ding R, Scheiner B, Wang SN, Li HL, Shen QX, Lu QY, Liu Y, Zhang WH, Luo B, Shi HB, Huang M, Wu YM, Yuan CW, Huang MS, Li JP, Wu JB, Zhu XL, Zhong BY, Zhou HF, Wang YQ, Gu SZ, Peng ZY, Zheng CS, Liu RB, Xu GH, Yang WZ, Xu AB, Liu DF, Qi X, Yeo YH, Zhu HD, Zhao Y, Pinato DJ, Ji F, Teng GJ. Longitudinal Body Composition Identifies Hepatocellular Carcinoma With Cachexia Following Combined Immunotherapy and Target Therapy (CHANCE2213). J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2705-2716. doi: 10.1002/jcsm.13615. Epub 2024 Nov 27.
PubMed 39604073
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Prognosis of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Hepatocellular Carcinoma by Using Clinical and Imaging Biomarkers
- ClinicalTrials.gov ID
- NCT05278195
- Acronym / sponsor ID
- CHANCEsub / CHANCE-Biomarker
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, immune checkpoint iInhibitors, transarterial chemoembolization, real-world study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Mar 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.
The purpose of this study is to id
transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular targeted therapies in patients with hepatocellular carcinoma (HCC) .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions.
Key inclusion criteria (6 listed)
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment;
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
Key exclusion criteria (3 listed)
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Missing follow-up data;
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
Overall Survival(OS)
Time frame: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
4 secondary outcomes
Specificity
Time frame: baseline
Sensitivity
Time frame: baseline
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiomics artificial intelligence mode
Time frame: baseline
Accuracy
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 32430997Llovet JM, Villanueva A, Marrero JA, Schwartz M, Meyer T, Galle PR, Lencioni R, Greten TF, Kudo M, Mandrekar SJ, Zhu AX, Finn RS, Roberts LR; AASLD Panel of Experts on Trial Design in HCC. Trial Design and Endpoints in Hepatocellular Carcinoma: AASLD Consensus Conference. Hepatology. 2021 Jan;73 Suppl 1:158-191. doi: 10.1002/hep.31327. Epub 2020 Sep 9. No abstract available.
- Background: PubMed 33479224Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.
- Background: PubMed 32888471Ochoa de Olza M, Navarro Rodrigo B, Zimmermann S, Coukos G. Turning up the heat on non-immunoreactive tumours: opportunities for clinical development. Lancet Oncol. 2020 Sep;21(9):e419-e430. doi: 10.1016/S1470-2045(20)30234-5.
- Background: PubMed 34593621Pinato DJ, Murray SM, Forner A, Kaneko T, Fessas P, Toniutto P, Minguez B, Cacciato V, Avellini C, Diaz A, Boyton RJ, Altmann DM, Goldin RD, Akarca AU, Marafioti T, Mauri FA, Casagrande E, Grillo F, Giannini E, Bhoori S, Mazzaferro V. Trans-arterial chemoembolization as a loco-regional inducer of immunogenic cell death in hepatocellular carcinoma: implications for immunotherapy. J Immunother Cancer. 2021 Sep;9(9):e003311. doi: 10.1136/jitc-2021-003311.
- Derived from this study: PubMed 41188158Chen Q, Lin LW, Jin ZC, Xiong B, Hu HT, Chen JJ, Zhou GH, Zhou HF, Ding R, Zhu XL, Huang M, Shi HB, Zhao ZW, Ji JS, Yang WZ, Xu GH, Xu AB, Hu ZC, Wang WD, Zhao C, Zhu HD, Teng GJ. The METAL Score for Early Stratification of Radiological Response and Survival in Hepatocellular Carcinoma Treated with TACE and Immunotherapy Combinations. Acad Radiol. 2026 Jan;33(1):47-58. doi: 10.1016/j.acra.2025.10.027. Epub 2025 Nov 4.
- Derived from this study: PubMed 39604073Jin ZC, Zhou JW, Chen JJ, Ding R, Scheiner B, Wang SN, Li HL, Shen QX, Lu QY, Liu Y, Zhang WH, Luo B, Shi HB, Huang M, Wu YM, Yuan CW, Huang MS, Li JP, Wu JB, Zhu XL, Zhong BY, Zhou HF, Wang YQ, Gu SZ, Peng ZY, Zheng CS, Liu RB, Xu GH, Yang WZ, Xu AB, Liu DF, Qi X, Yeo YH, Zhu HD, Zhao Y, Pinato DJ, Ji F, Teng GJ. Longitudinal Body Composition Identifies Hepatocellular Carcinoma With Cachexia Following Combined Immunotherapy and Target Therapy (CHANCE2213). J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2705-2716. doi: 10.1002/jcsm.13615. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Gao-Jun Teng, M.D. principal investigator
Zhongda hospital, Southeast university, Nanjing, China
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 Zhongda 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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao-Jun Teng, M.D. (+86-02583272121, gjteng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: up to approximately 2 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 NCT05278195, which also lists 6 linked publications.
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 14 Mar 2022.