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Status unknownNCT05278195CHANCEsubUpdated Mar 14, 2022

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 in Hepatocellular Carcinoma, sponsored by Zhongda Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Zhongda Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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) .

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • immune checkpoint iInhibitors
  • transarterial chemoembolization
  • real-world study
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 300 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Zhongda Hospital is the lead sponsor of 101 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
  2. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
  3. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
  4. 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;
  5. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
  1. Has repeated measurable intrahepatic lesions according to RECIST v1.1;

Exclusion criteria

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
  2. Unable to meet criteria of combination timeframe described above;
  3. Missing follow-up data;
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Overall Survival(OS)

    The OS is defined as the time from the initiation of any combination treatment to death due to any cause.

    Time frame: up to approximately 2 years

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: baseline

  3. 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.

    Time frame: baseline

  4. Accuracy

    Defined by a confusion matrix of sensitivity and specificity to true positives and true negatives.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital, Southeast University
    Nanjing, Jiangsu 210009, China
    Recruiting
08

References and documents

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 32430997 ↗
  • Llovet 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. Erratum In: Nat Rev Dis Primers. 2024 Feb 12;10(1):10. doi: 10.1038/s41572-024-00500-6. PubMed 33479224 ↗
  • Ochoa 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 32888471 ↗
  • Pinato 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 34593621 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05278195
Lead sponsor
Zhongda Hospital
Responsible party
Gao-jun Teng (President, Zhongda Hospital) — Principal investigator
First posted
Mar 14, 2022
Start date
Apr 1, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Mar 14, 2022

Study contacts

Gao-Jun Teng, M.D.
Contact
gjteng@vip.sina.com
+86-02583272121
Hai-Dong Zhu, M.D.
Contact
zhuhaidong9509@163.com
+86-02583272121
Gao-Jun Teng, M.D.
principal investigator · Zhongda hospital, Southeast university, Nanjing, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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