TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
In China, the majority of hepatocellular carcinoma (HCC) cases stem from chronic hepatitis B virus (HBV) infection and subsequent cirrhosis, with patients often presenting at the decompensated stage complicated by clinically significant portal hypertension (CSPH). CSPH not only limits treatment options and worsens prognosis but also leads to the frequent exclusion of such patients from pivotal clinical trials, resulting in a lack of high-level evidence for their management. Carvedilol, a non-selective beta-blocker, is a first-line therapy for portal hypertension. Emerging evidence suggests that this drug class may also modulate the tumor microenvironment and enhance the efficacy of immune checkpoint inhibitors.
To address this unmet need, this study aims to explore a novel quadruple-therapy strategy (TACE + tislelizumab + lenvatinib + carvedilol) for the treatment of unresectable HCC with concurrent cirrhotic portal hypertension. The rationale is twofold: while controlling portal hypertension and safeguarding treatment safety, carvedilol may also potentiate immunotherapy by modulating adrenergic signaling, thereby achieving dual benefits of "liver protection" and "anti-cancer" synergy. Utilizing an efficient Simon's two-stage design, this study will conduct a preliminary assessment of the regimen's efficacy and safety with minimal risk, providing essential data to inform future confirmatory research.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years.
At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (tumor lesion long axis ≥10 mm on CT scan).
Newly diagnosed hepatocellular carcinoma without any prior treatment for HCC.
Child-Pugh liver function score ≤ 7.
Disqualifiers
Decompensated cirrhosis.
Concurrent other malignancies or recurrent HCC.
Any active, known, or suspected autoimmune disease.
History of allergy to any component of PD-1 inhibitors, lenvatinib, or carvedilol.
Trial design
Design model
Single group
Treatments tested in this trial
TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol
DrugAll the enrolled patients received standard first-line treatment (TACE combined with tiragolumab and lenvatinib) and were additionally treated with carvedilol. The treatment duration of the study was one year. After the end of the treatment, the patients would be evaluated by the researchers to determine whether to continue the treatment or switch to other first-line treatments.
Treatment groups
78 Participants
are divided into 1 treatment groupGroup A: TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate(ORR)
ORR is defined as the proportion of patients who achieved the best therapeutic response of PR or CR among all the patients enrolled.
Time frame
From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.Secondary outcomes
1
Progression-free survival(PFS)
PFS is defined as the time from study enrollment to the first occurrence of disease progression.
Time frame
From the date of enrollment, until the tumor progresses, the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.2
Overall survival(OS)
OS is defined as the time from the start of the study enrollment to death.
Time frame
From the date of enrollment, until the patient dies, the assessment period can last up to 60 months.3
Adverse events (AEs)
AE is defined as any event that occurs during the treatment period and is not related to the purpose of the treatment which assessed by CTCAE v4.0.
Time frame
From the baseline up to 12 months.4
The rate of decompensation of liver cirrhosis
The definition of decompensated portal hypertension in liver cirrhosis is the occurrence of clinical events such as upper gastrointestinal bleeding, hepatic encephalopathy, and liver function failure during the treatment period.
Time frame
From the date of enrollment, until the patient dies, or the study concludes (whichever occurs first), the assessment period can last up to 60 months.Other outcomes
1
Difference in treatment effect (Hazard Ratio) between participants with emotional disorders versus non-emotional disorders, assessed by the interaction p-value.
To explore the efficacy difference of the quadruple therapy between pre-defined subgroups. The primary efficacy endpoint (e.g., Progression-Free Survival) will be analyzed separately within each subgroup (emotional disorders vs. non-emotional disorders).
Time frame
From baseline until death, study conclusion, or up to 60 months (whichever occurs first).Sponsors and contacts
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Source ClinicalTrials.gov
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