Other Clinical Trial - Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for

Status Recruiting

Clinical Trial Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

Clinical Trial Description

This is a multicenter, prospective and randomized controlled trial to evaluate the efficacy and safety of Sin-Bev-TACE versus Len-TACE for patient with advanced HCC. 258 patients with advanced HCC (BCLC C stage) will be enrolled in this study. The patients will receive either sintilimab and bevacizumab (Sin-Bev) or lenvatinib (Len) after first TACE using an 1:1 randomization scheme. In the Sin-Bev-TACE arm, sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) will be started at 3-7 days after the first TACE. In the the Len-TACE arm, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand based on the evaluation of follow-up laboratory and imaging examination. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the Sin-Bev-TACE arm, patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity. The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Hepatocellular
Hepatocellular Carcinoma Non-resectable

Clinical Trial Details

NCT number	NCT05985798
Study type	Interventional
Source	Second Affiliated Hospital of Guangzhou Medical University
Contact	Mingyue Cai, Dr.
Phone	+86-20-34156205
Email	cai020@yeah.net
Status	Recruiting
Phase	Phase 3
Start date	August 1, 2023
Completion date	July 31, 2027

View Details

See also
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Recruiting	`NCT05031949` - Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma	Phase 1
Completed	`NCT03533920` - Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma	N/A
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Not yet recruiting	`NCT05057104` - Non-inferiority Study of Unresectable Hepatocelluar Carcinoma Receiving Stereotactic Radiotherapy Combined With Hepatic Arterial Chemoembolization Compared With Conversion Hepatectomy
Completed	`NCT04599790` - TACE Combined With Lenvatinib and Sintilimab for Advanced HCC	Phase 2
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Completed	`NCT04926376` - Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC	N/A
Recruiting	`NCT06133062` - Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma	Phase 2
Completed	`NCT02989922` - A Study to Evaluate SHR-1210 in Subjects With Advanced HCC	Phase 2
Recruiting	`NCT04273100` - PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC	Phase 2
Completed	`NCT06408753` - Plasma Biomarker in Predicting Response and Toxicity in HCC Patients Treated With Checkpoint Inhibitors With or Without SBRT
Withdrawn	`NCT03563170` - QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine	Phase 1/Phase 2
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms