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

Hepatocellular Carcinoma Clinical Trial

— CHANCE001  

Official title:

Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975932
• Other study ID #: TACE-ICIs-RWS
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: July 2023
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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) in patients with hepatocellular carcinoma (HCC) .

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 TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: February 8, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• TACE+ICIs
TACE plus ICIs ( with or without molecular targeted therapies)

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

Locations

Country	Name	City	State
China	Gao-Jun Teng	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival(OS)	The OS is defined as the time from the initiation of any combination treatment to death from any cause.	up to approximately 2 years
Secondary	Time to Progression(TTP)	The TTP is defined as the time from the initiation of any combination treatment to progression according to mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm.	up to approximately 1 years
Secondary	Objective response rate(ORR)	The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST.	6-8 week after TACE
Secondary	Disease control rate(DCR)	The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST.	6-8 week after TACE
Secondary	Adverse event(AE)	Number and degree of the AEs according to CTCAE version 5.0.	baseline to end of study (approximately 2 years)