Health TrialsbyHealthPanel

Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZe-yang Ding, MD

About this trial

This study is conducted to evaluate the efficacy, prognosis, adverse effects, and factors for predicting therapeutic effects and clinical prognosis of combined therapy of hepatic artery infusion chemotherapy (HAIC), tyrosine kinase inhibitor/ anti-VEGF antibody, and anti-PD-1/ PD-L1 antibody for advanced hepatocellular carcinoma which initially unsuitable for the radical therapy, including resection, transplantation, or ablation. Factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

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

Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured

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

Prospective

Treatments tested in this trial

  • HAIC

    Procedure/Surgery

    administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

  • Bevacizumab plus Atezolizumab

    Drug

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

  • Bevacizumab Biosimilar IBI305 plus sintilimab

    Drug

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

  • Lenvatinib

    Drug

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

  • Sorafenib

    Drug

    400mg; p.o. bid

  • Donafenib

    Drug

    200mg; p.o. bid

  • Regorafenib

    Drug

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

  • apatinib plus camrelizumab

    Drug

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

  • Anti-PD-1 monoclonal antibody

    Drug

    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).

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

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

overall response rate (ORR) 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; Stable disease (SD): Any cases that do not qualify for either partial response or progressive disease; Progressive disease (PD): An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. ORR=CR+PR.

Time frame
rom the date of first treatment to radiographically documented progression according to mRECIST, 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 mRECIST, 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, 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.

Ze-yang Ding, MD

Lead sponsor

Tongji Hospital

Sponsor institution

Chinese Cooperative Group of Liver Cancer

Collaborator

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

Collaborator

Haplox Biotechnology Co., Ltd.

Collaborator

Geneplus-Beijing Co. Ltd.

Collaborator

The Second Affiliated Hospital of Fujian Medical University

Collaborator

Source ClinicalTrials.gov
Apply now