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Hepatocellular CarcinomaCHANCE2201NCT05332821

TACE in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies for Advanced HCC

An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies in patients with advanced-stage hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab and TACE
Type of treatment
Surgery or procedure
How many people
1,244 participants
Where
2 sitesChina
Study dates
28 Dec 2022to 10 Jan 2024
How long will I take part?
12 Months
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 advanced 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;
  • Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
  • 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 after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment;
  • Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment；
  • Has repeated measurable intrahepatic lesions;

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;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Gao-Jun Teng

    Nanjing

  • Zheng-Gang Ren

    Shanghai

Other trials in China

About this study

Official title: Efficacy and Safety of Transarterial Chemoembolization in Combination With PD-1/PD-L1 Inhibitors and Molecular Target Therapies(VEGF-TKI/Bevacizumab) for Advanced Stage HCC

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies in patients with advanced-stage hepatocellular carcinoma (HCC).

Read the detailed description

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies(including, VEGF-TKI/ bevacizumab) in patients with advanced-stage HCC. This real-world study also would like to explore the optimal combined treatment and subgroup of HCC patients for providing further information for clinical practice and trials.

Being tested
PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab, TACE
Keywords
hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint inhibitors, molecular target therapies, advanced stage
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumabDrug

    PD-1/PD-L1 inhibitors: atezolizumab, sintilimab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, toripalimab, durvalumab, penpulimab, and other ICIs; VEGF-TKI/bevacizumab: sorafenib, lenvatinib, donafenib, apatinib, anlotinib, bevacizumab/ bevacizumab biosimilar, and other anti-angiogenesis drugs; Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs only include marketed drugs but are not limited to HCC approval.

  • TACEProcedure or surgery

    TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

Study groups in NCT05332821
Study groupRoleWhat they receive
Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumabTACE was performed up to 3 months after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
Receives: Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab; Procedure: TACE
Control group: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumabThe interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；
Receives: Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (9)

  1. Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.

    Measured: up to approximately 2 years

  2. PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.

    Measured: up to approximately 2 years

  3. Objective response rate(ORR) per RESCIST 1.1

    The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.

    Measured: up to approximately 2 years

  4. Duration of Response (DOR) per RESCIST 1.1

    DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.

    Measured: up to approximately 2 years

  5. Disease Control Rate (DCR) per RESCIST 1.1

    DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.

    Measured: up to approximately 2 years

  6. ORR per mRECIST

    The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.

    Measured: up to approximately 2 years

  7. DOR per mRECIST

    DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.

    Measured: up to approximately 2 years

  8. DCR per mRECIST

    DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.

    Measured: up to approximately 2 years

  9. Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0

    The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.

    Measured: up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start28 Dec 2022
  3. Primary completion30 Jul 2023
  4. Study completion10 Jan 2024

Resources

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
Other
Enrolment
1,244 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332821
Sponsor's protocol ID
CHANCE2201
Acronym
CHANCE2201
Status last verified
Apr 2026
First submitted
2 Apr 2022
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
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 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.

    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

  • Jin ZC, Chen JJ, Zhu XL, Duan XH, Xin YJ, Zhong BY, Chen JZ, Tie J, Zhu KS, Zhang L, Huang M, Piao MJ, Li X, Shi HB, Liu RB, Xu AB, Ji F, Wu JB, Shao GL, Li HL, Huang MS, Peng ZY, Ji JS, Yuan CW, Liu XF, Hu ZC, Yang WZ, Yin GW, Huang JH, Ge NJ, Qi X, Zhao Y, Zhou JW, Xu GH, Tu Q, Lin HL, Zhang YJ, Jiang H, Shao HB, Su YJ, Chen TS, Shi BQ, Zhou X, Zhao HT, Zhu HD, Ren ZG, Teng GJ; CHANCE2201 Investigators. Immune checkpoint inhibitors and anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors with or without transarterial chemoembolization as first-line treatment for advanced hepatocellular carcinoma (CHANCE2201): a target trial emulation study. EClinicalMedicine. 2024 May 6;72:102622. doi: 10.1016/j.eclinm.2024.102622. eCollection 2024 Jun.

    PubMed 38745965

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital at 2 sites 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 7 inclusion and 2 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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 NCT05332821, which also lists 5 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 17 Apr 2026.

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