Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC (TACE-3)

  • STATUS
    Recruiting
  • End date
    Jun 25, 2026
  • participants needed
    522
  • sponsor
    The Clatterbridge Cancer Centre NHS Foundation Trust
Updated on 27 February 2022
platelet count
renal function
liver transplant
neutrophil count
TACE
nivolumab

Summary

This study evaluates the addition of nivolumab to TACE/TAE in the treatment of patients with intermediate stage hepatocellular carcinoma. All patients will receive TACE/TAE and half will receive nivolumab.

Description

A significant proportion of HCC patients present with, or progress to, intermediate stage disease and these patients are typically treated with transarterial chemo-embolisation (TACE) or transarterial embolisation (TAE).

However, since TACE/TAE is generally a palliative therapy, it provides a potential backbone for the addition of effective systemic therapies with the aim of improving survival outcomes. Since TACE may liberate an abundance of tumour antigens and 'danger' signals, it may lend itself to combination with immunotherapeutic strategies.

Nivolumab is a human monoclonal antibody. Nivolumab targets the programmed death-1 PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.

Details
Condition Hepatocellular Carcinoma
Treatment TACE, Nivolumab and TACE, Nivolumab and TACE/TAE, TACE/TAE
Clinical Study IdentifierNCT04268888
SponsorThe Clatterbridge Cancer Centre NHS Foundation Trust
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological diagnosis of HCC and at least one uni-dimensional lesion measurable according to RECIST 1.1 criteria by CT-scan or MRI
Not a candidate for surgical resection or liver transplantation
Aged 16 years and estimated life expectancy >3 months
ECOG performance status 0-1
Adequate haematological function
Hb 9g/L
Absolute neutrophil count 1.0x109/L
Platelet count 60x109/L
Bilirubin 50 mol/L, AST,ALT and ALP 5 x ULN
Adequate renal function; Creatinine 1.5ULN (Using Cockcroft-Gault Formula)
INR 1.6
Child-Pugh A (score 6) (Appendix D)
HAP score A, B or C (Appendix E)
No contra-indications to T-cell checkpoint inhibitor therapy (use of immunosuppressive drugs including steroids at dose equivalent to prednisolone >10mg/day unless used as replacement therapy; organ transplantation; subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, lichen planus or other conditions not expected to recur in the absence of an external trigger are permitted to enrol)
Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 5 months after completion of treatment for women and 7 months for men
Written informed consent

Exclusion Criteria

Extrahepatic metastasis
Prior embolisation, systemic or radiation therapy for HCC
Any contraindications for hepatic embolisation procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis
Investigational therapy or major surgery within 4 weeks of trial entry
History of variceal bleeding within the past 4 weeks
Child-Pugh cirrhosis B or C (score 7)
HAP score D
Hepatic encephalopathy
Ascites refractory to diuretic therapy
Documented occlusion of the hepatic artery or main portal vein5
Hypersensitivity to intravenous contrast agents
Active clinically serious infection > Grade 2 NCI-CTC
Pregnant or lactating women
Known history of HIV infection
HBV chronic infection with HBV DNA > 500IU/mL or without antiviral therapy; HBV patients with cirrhosis should be treated
History of second malignancy except those treated with curative intent more than three years previously without relapse and non-melanotic skin cancer or cervical carcinoma in situ 18. Evidence of severe or uncontrolled systemic disease, or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial 19. Psychiatric or other disorder likely to impact on informed consent 20. Patient is unable and/or unwilling to comply with treatment and study instructions 20. Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
Evidence of uncontrolled, active infection, requiring parenteral anti-bacterial, anti-viral or antifungal therapy within 7 days prior to administration of study medication
Positive test for latent TB or evidence of active TB
Hypersensitivity to any of the active substances or excipients
Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of the first dose of study drug administration
Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis
Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol
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