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

NCT05332821 | Completed

• 1 other identifier: CHANCE2201
• Study Type: observational
• Target: 1,244
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; transarterial chemoembolization; immune checkpoint inhibitors; molecular target therapies; advanced stage

Outcome Measures

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.

  up to approximately 2 years

Secondary Outcomes (9)

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

  up to approximately 2 years

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

  up to approximately 2 years

• Objective response rate(ORR) per RESCIST 1.1

  up to approximately 2 years

• Duration of Response (DOR) per RESCIST 1.1

  up to approximately 2 years

• Disease Control Rate (DCR) per RESCIST 1.1

  up to approximately 2 years

Study Arms (2)

Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

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. The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；

Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab; Procedure: TACE

Control group: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

The interval between first use PD-1/PD-L1 inhibitors and anti-angiogenesis drugs ≤1 week；

Drug: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Interventions

PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab DRUG

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.

Control group: PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab; Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

TACE PROCEDURE

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

Study group: TACE+PD-1/PD-L1 inhibitors+VEGF-TKI/bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (2)

Gao-Jun Teng

Nanjing, China

Location

Zheng-Gang Ren

Shanghai, China

Location

Related Publications (5)

• 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.

  PMID: 32430997 BACKGROUND

• 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.

  PMID: 33479224 BACKGROUND

• 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.

  PMID: 32888471 BACKGROUND

• 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.

  PMID: 34593621 BACKGROUND

• 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.

  PMID: 38745965 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gao-Jun Teng, M.D.

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

• Zheng-Gang Ren, M.D.

  Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 18, 2022
• Study Start: December 28, 2022
• Primary Completion: July 30, 2023
• Study Completion: January 10, 2024
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)