Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

NCT04975932 | Completed

• 1 other identifier: TACE-ICIs-RWS
• Study Type: observational
• Target: 826
• Locations: 1 country
• Sites: 1

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) in patients with hepatocellular carcinoma (HCC) .

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; transarterial chemoembolization; immune checkpoint iInhibitors; real-world study

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  The PFS is defined as the time from the initiation of any combination treatment to progression according to mRECIST or death from any cause. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).

  up to approximately 1 years

Secondary Outcomes (5)

• Overall survival(OS)

  up to approximately 2 years

• Time to Progression(TTP)

  up to approximately 1 years

• Objective response rate(ORR)

  6-8 week after TACE

• Disease control rate(DCR)

  6-8 week after TACE

• Adverse event(AE)

  baseline to end of study (approximately 2 years)

Study Arms (2)

Study group: TACE+ICIs

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs

Other: TACE+ICIs

Control group: TACE

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

Procedure: TACE

Interventions

TACE+ICIs OTHER

TACE plus ICIs ( with or without molecular targeted therapies)

Study group: TACE+ICIs

TACE PROCEDURE

TACE without combination of ICIs ( with or without molecular targeted therapies)

Control group: TACE

Eligibility Criteria

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

Study Population

Patients with HCC who are candidates for TACE combined with ICIs therapies under real-world practice conditions.

You may qualify if:

• diagnosed with HCC by radiology, histology, or cytology;
• patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
• during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
• patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.

You may not qualify if:

• exceeding the time interval of the combination therapy defined above;
• missing follow-up data;

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Gao-Jun Teng

Nanjing, China

Location

Related Publications (2)

• Zhu HD, Li HL, Huang MS, Yang WZ, Yin GW, Zhong BY, Sun JH, Jin ZC, Chen JJ, Ge NJ, Ding WB, Li WH, Huang JH, Mu W, Gu SZ, Li JP, Zhao H, Wen SW, Lei YM, Song YS, Yuan CW, Wang WD, Huang M, Zhao W, Wu JB, Wang S, Zhu X, Han JJ, Ren WX, Lu ZM, Xing WG, Fan Y, Lin HL, Zhang ZS, Xu GH, Hu WH, Tu Q, Su HY, Zheng CS, Chen Y, Zhao XY, Fang ZT, Wang Q, Zhao JW, Xu AB, Xu J, Wu QH, Niu HZ, Wang J, Dai F, Feng DP, Li QD, Shi RS, Li JR, Yang G, Shi HB, Ji JS, Liu YE, Cai Z, Yang P, Zhao Y, Zhu XL, Lu LG, Teng GJ; CHANCE001 Investigators. Transarterial chemoembolization with PD-(L)1 inhibitors plus molecular targeted therapies for hepatocellular carcinoma (CHANCE001). Signal Transduct Target Ther. 2023 Feb 8;8(1):58. doi: 10.1038/s41392-022-01235-0.

  PMID: 36750721 RESULT

• Jin ZC, Zhong BY, Chen JJ, Zhu HD, Sun JH, Yin GW, Ge NJ, Luo B, Ding WB, Li WH, Chen L, Wang YQ, Zhu XL, Yang WZ, Li HL, Teng GJ; CHANCE Investigators. Real-world efficacy and safety of TACE plus camrelizumab and apatinib in patients with HCC (CHANCE2211): a propensity score matching study. Eur Radiol. 2023 Dec;33(12):8669-8681. doi: 10.1007/s00330-023-09754-2. Epub 2023 Jun 27.

  PMID: 37368105 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, MD

  Zhongda hospital, Southeast university, Nanjing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 26, 2021
• Study Start: July 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: February 8, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)