Clinical trial NCT06232759: TACE Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma
Official title: Transarterial Chemoembolization Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with unresectable hepatocellular carcinoma were received transarterial chemoembolization combined with Tyrosine Kinase Inhibitors and Tislelizumab
Primary purpose: TREATMENT

Brief summary: Most hepatocellular carcinoma (HCC) are found in the intermediate or advanced stage. The patients lose the opportunity of curative surgical resection. In clinical practice, unresectable HCC is often encountered with large tumor lesions and insufficient remaining liver volume. It is expected that the benefit of direct surgical resection will not exceed that of non-surgical treatment if the tumor is limited in scope but with unclear boundaries, surrounding small foci, or adjacent to important vascular structures, or combined with secondary or higher portal vein tumor thrombus. These patients account for a significant proportion of unresectable HCC, but have the potential for surgical resection. If the investigators can make full use of the existing HCC treatment, the patients hope to obtain radical surgical resection opportunities and better long-term survival after tumor shrinkage and tumor necrosis boundary becomes clear.

Transcatheter arterial chemoembolization (TACE) has been the standard arterial treatment for advanced HCC. Tyrosine kinase Inhibitor is the first-line treatment for hepatocellular carcinoma. Tislelizumab is an immune checkpoint inhibitor and a first-line treatment for HCC. This study investigated the efficacy and safety of TACE combined with Tyrosine Kinase Inhibitors and tislelizumab in the treatment of unresectable HCC.


Eligibility criteria: Inclusion Criteria:

* Had Child-Pugh score 5-7 liver function, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function at the time of treatment initiation;
* With stage Ⅰb, Ⅱa, Ⅱb or Ⅲa hepatocellular carcinoma (HCC) based on the Chinese liver Cancer Staging System (CNLC);
* With unresectable HCC because of insufficient residual liver volume;
* Expected survival time ≥6 months;
* Hematology indexes should meet the following conditions: hemoglobin ≥90 g/L; platelet ≥80; total bilirubin ≤1.5×ULN; alanine transaminase ≤3×ULN; aspertate aminotransferase ≤ 3 x ULN; alkaline phosphatase ≤2.5×ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5×ULN;
* Urinary protein \<2+ or 24 h urinary protein quantity \< 1.0g;
* For women of reproductive age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) are required during the clinical trial until 120 days after the end of the clinical trial; Women of childbearing age had negative serum or urine HCG test results within 7 days prior to inclusion in the study; For male patients whose partners have reproductive potential, effective contraception should be used during the study period and for 120 days after the end of the study.

Exclusion Criteria:

* Combined with other malignant tumors;
* Previously received local treatment of HCC such as Hepatic Artery Infusion Chemotherapy, transarterial (chemo)embolization, or local ablation;
* Those who have received or are using one of the following three types of drugs in the past 6 months: Immune checkpoint inhibitors, including but not limited to Atezolizumab, Nivolumab, pembrolizumab, Camrelizumab, Tislelizumab, triplizumab, sintilimab, etc.; Molecular targeted therapy, including but not limited to sorafenib, lenvatinib, donafenib, apatinib, regorafenib, anrotinib, bevacizumab, etc.; systemic chemotherapy drugs (such as doxorubicin, oxaliplatin, 5-FU, S-1, etc.);
* The presence of congenital or acquired immunodeficiency diseases (such as HIV positive);
* Active infection, or body temperature ≥ 38.5℃ 7 days before enrollment.

Primary outcomes:
measure: Progression-free survival
timeFrame: One year
Secondary outcomes:
measure: Overall survival
timeFrame: One year
Other outcomes:
Locations:
city: Nanning
country: China
facility: Jian-Hong Zhong
state: Guangxi
Study officials:
affiliation: The Eighth Affiliated hospital of the Guangxi Medical University
name: Shao-Ping Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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