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Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

The aim of this study is to the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of transarterial chemoembolization (TACE), Anti-VEGF antibodies or pan-target anti-angiogenic drugs, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management;

at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Disqualifiers

Persistent or activity (except the HBV and HCV) infection;

symptoms of congestive heart failure and uncontrolled diabetes;

uncontrolled hypertension, systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg despite anti-hypertension medications ≤ 28 days before randomization or first dose of drug.

unstable angina,

Trial population

Patients with advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • TACE

    Procedure/Surgery

    Procedure of TACE is standardized.

  • Lenvatinib

    Drug

    8mg; p.o.; q.d.

  • Anti-PD-1 monoclonal antibody

    Drug

    Advanced HCC Patients treated with TKI plus anti-PD-1 monoclonal antibody as systemic therapy were recruited. Anti-PD-1 monoclonal antibodies include pembrolizumab (200 mg, q3w), nivolumab (3mg/kg, q2w), camrelizumab (200mg, q2w), tislelizumab (200mg, q3w), sintilimab (200 mg, q3w), or toripalimab (240mg, q3w).

  • Bevacizumab Biosimilar IBI305 plus sintilimab

    Drug

    Bevacizumab Biosimilar IBI305 (15mg/kg, q3w), and sintilimab (200 mg, q3w)

  • Bevacizumab plus Atezolizumab

    Drug

    Bevacizumab (15mg/kg, q3w) plus Atezolizumab (1200 mg, q3w)

  • apatinib plus camrelizumab

    Drug

    Apatinib(250 mg; p.o.; q. d.); camrelizumab (200 mg; iv drip; q2w)

  • Sorafenib

    Drug

    400mg; p.o. bid

  • Donafenib

    Drug

    200mg; p.o. bid

  • Regorafenib

    Drug

    160 mg; p.o.; q.d.

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: TACE-Len-ICI cohort3 interventions
Group B: TACE-A-T cohort2 interventions
Group C: TACE-B-S cohort2 interventions
Group D: TACE-Apa-C cohort2 interventions
Group E: TACE-Sor-ICI cohort3 interventions
Group F: TACE-Don-ICI cohort3 interventions
Group G: TACE-Reg-ICI cohort3 interventions

Trial outcomes

Primary outcomes

1

Number of Patients Amendable to Curative Surgical Interventions

Number of patients amendable to curative surgical interventions defined as number of patients receiving curative surgical resection, transplantation, or ablation after successful down-sizing of tumor(s) by intervention.

Time frame
from the date of first treatment to the date of last treatment, an average of 3 years

Secondary outcomes

1

Response Rate measured by mRECIST criteria

Complete response (CR): Disappearance of any intra-tumoral arterial enhancement in all target lesions; Partial response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. Response rate is the rate of CR plus PR.

Time frame
from the date of first treatment to radiographically documented progression according to mRECIST v1.1, assessed up to 3 years
2

Time to progression (TTP)

Time to progression (TTP): measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1. This does not include death from any cause.

Time frame
from the date of first treatment to radiographically documented progression according to mRECIST1.1, assessed up to 3 years
3

Time to intrahepatic tumor progression (TTITP)

Time to intrahepatic tumor progression (TTITP): measured from the date of first treatment to radiographically documented intrahepatic tumor progression according to mRECIST 1.1. This does not include death from any cause.

Time frame
from the date of first treatment to radiographically documented intrahepatic tumor progression according to mRECIST 1.1, assessed up to 3 years
4

Progression-free survival (PFS)

measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.

Time frame
from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Chinese Cooperative Group of Liver Cancer

Collaborator

Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

Geneplus-Beijing Co. Ltd.

Collaborator

Haplox Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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