NCT06254248: IMMUNO-TH

Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma

Recruiting now Phase 2 Last updated 10 March 2026

What this trial tests

Phase 2 trial testing Systemic therapy in Liver Transplant in 50 participants. Currently enrolling.

Timeline

22 January 2026

Primary endpoint
1 January 2030

1 January 2030

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	22 January 2026
Primary completion	1 January 2030
Estimated completion	1 January 2030
Sites	10 locations across France

Drugs / interventions tested

• Systemic therapy — full drug profile →

Conditions studied

• Liver Transplant — all drugs for Liver Transplant →
• Hepatocellular Carcinoma Recurrent — all drugs for Hepatocellular Carcinoma Recurrent →
• Systemic Treatment — all drugs for Systemic Treatment →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 90, any sex, with Liver Transplant or Hepatocellular Carcinoma Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prognosis of liver transplanted (LT) patients with recurrence of hepatocellular carcinoma (HCC), especially those with progression after locoregional treatment or advanced HCC, remains poor. Current treatment modalities involve tyrosine kinase inhibitors (TKIs) characterized by a low response rate and often poor tolerability. Encouraging findings from the Imbrave 150 study, demonstrating increased survival rates coupled with favorable treatment tolerance, prompt the investigators to consider the potential of offering the combination of treatment with Atezolizumab-Bevacizumab (Atezo-Beva) to patients with LT. No data regarding the safety and efficacy of this new combination are available for patients with LT as they were not included in Imbrave 150. Immunosuppression after LT is low when compared to essentially all other organ recipients, liver recipients are considered with lower immunological risk. However, the use of ICIs has been associated with a risk of hepatic rejection in LT patients. In this study, in order to prevent acute cellular rejection (ACR) occurrence, we propose to adopt a standardized immunosuppressive regimen closed to the one used immediately after LT but with lower therapeutic goals for tacrolimus and everolimus to allow immunotherapy treatment to be effective. The better tolerance of liver grafts will probably lead to less risk of rejection with Atezo-Beva than in other organ transplants.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Challenges in Liver Transplantation for Hepatocellular Carcinoma: A Review of Current Controversies.
   Mauro E, Sanduzzi-Zamparelli M, Jutras G, Garcia R, et al · · 2024 · cited 7× · PMID 39272917 · DOI 10.3390/cancers16173059
2. Recurrence of Hepatocellular Carcinoma After Liver Transplantation: The Blind Spot of HCC Management.
   Ningarhari M, Lassailly G, Dharancy S, Moreno C, et al · · 2025 · cited 2× · PMID 40616813 · DOI 10.1002/ueg2.70078
3. Systemic Treatment for Hepatocellular Carcinoma Recurrence After Liver Transplantation.
   Mazzarelli C, Associazione Italiana per lo Studio del Fegato (AISF) HCC Special Interest Group, Berardi F, Bonfichi A, et al · · 2026 · PMID 41892169 · DOI 10.3390/curroncol33030141
4. Immunological Crossroads: Optimizing Antirejection Regimens to Sustain Antitumor Immunity in Liver Transplant Recipients with Hepatocellular Carcinoma.
   Zhang C, Yuan X, Xie K. · · 2025 · PMID 41375072 · DOI 10.3390/cancers17233871
5. Review Article: Liver Transplantation for Hepatocellular Carcinoma in the Era of Immune Checkpoint Inhibitors.
   Kulkarni AV, Singal AG, Reddy KR. · · 2025 · PMID 40808313 · DOI 10.1111/apt.70333