Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust
• Treatments: Chlorotrianisene; Nivolumab

Criteria

Inclusion Criteria:

1. Histological diagnosis of HCC and at least one uni-dimensional lesion measurable according to RECIST 1.1 criteria by CT-scan or MRI.

2. Not a candidate for surgical resection or liver transplantation

3. Aged ≥16 years and estimated life expectancy >3 months

4. ECOG performance status 0-1

5. Adequate haematological function:

• Hb ≥9g/L

• Absolute neutrophil count ≥1.0x109/L

• Platelet count ≥60x109/L

6. Bilirubin ≤50 μmol/L, AST,ALT and ALP ≤5 x ULN

7. Adequate renal function; Creatinine ≤ 1.5ULN (Using Cockcroft-Gault Formula)

8. INR ≤1.6

9. Child-Pugh A (score ≤6) (Appendix D)

10. HAP score A, B or C (Appendix E)

11. 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).

12. 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

13. Written informed consent

Exclusion Criteria:

1. Extrahepatic metastasis

2. Prior embolisation, systemic or radiation therapy for HCC

3. Any contraindications for hepatic embolisation procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis

4. Investigational therapy or major surgery within 4 weeks of trial entry

5. History of variceal bleeding within the past 4 weeks

6. Child-Pugh cirrhosis B or C (score ≥7)

7. HAP score D

8. Hepatic encephalopathy

9. Ascites refractory to diuretic therapy

10. Documented occlusion of the hepatic artery or main portal vein5

11. Hypersensitivity to intravenous contrast agents

12. Active clinically serious infection > Grade 2 NCI-CTC

13. Pregnant or lactating women

14. Known history of HIV infection

15. HBV chronic infection with HBV DNA > 500IU/mL or without antiviral therapy; HBV patients with cirrhosis should be treated.

17. 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

21. Evidence of uncontrolled, active infection, requiring parenteral anti-bacterial, anti-viral or antifungal therapy within 7 days prior to administration of study medication

22. Positive test for latent TB or evidence of active TB

23. Hypersensitivity to any of the active substances or excipients

24. Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment

25. 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

26. Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis

27. 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