Clinical trial · Observational
Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study
Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study
NCT04975932CI-TRIAL-00068021CHANCE001completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Procedure | — | UNRESOLVED |
| TACE+ICIs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Study group: TACE+ICIs
- description
- TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs
- interventionNames
- Other: TACE+ICIs
- label
- Control group: TACE
- description
- TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- Progression free survival(PFS)
- timeFrame
- up to approximately 1 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. diagnosed with HCC by radiology, histology, or cytology; 2. 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; 3. 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; 4. patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy. Exclusion Criteria: 1. exceeding the time interval of the combination therapy defined above; 2. missing follow-up data;
References
Publications (2)
- RESULTZhu 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
- RESULTJin 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