Clinical trial NCT04975932: Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study
Official title: Efficacy and Safety of Transarterial Chemoembolization in Combination With Immune Checkpoint Inhibitors for Hepatocellular Carcinoma: a Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
transarterial chemoembolization
immune checkpoint iInhibitors
real-world study
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCC who are candidates for TACE combined with ICIs therapies under real-world practice conditions.

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) .

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 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Progression free survival(PFS)
timeFrame: up to approximately 1 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: up to approximately 2 years
measure: Time to Progression(TTP)
timeFrame: up to approximately 1 years
measure: Objective response rate(ORR)
timeFrame: 6-8 week after TACE
measure: Disease control rate(DCR)
timeFrame: 6-8 week after TACE
measure: Adverse event(AE)
timeFrame: baseline to end of study (approximately 2 years)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Gao-Jun Teng
Study officials:
affiliation: Zhongda hospital, Southeast university, Nanjing, China
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 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.
citation: 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.