Resectable Advanced HCC: Neoadjuvant Dual Checkpoint Immunotherapy

Phase II Neoadjuvant Trial Results

• August 12, 2021

At ESMO Gastrointestinal Cancers Congress (June-July 2021), researchers presented Phase II trial (NCT03510871) results evaluating nivolumab plus ipilimumab as neoadjuvant therapy in resectable advanced hepatocellular carcinoma.

Trial Design

Patient Population: Resectable advanced HCC (n=29)

Neoadjuvant Regimen:

• Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg
• Every 3 weeks (3-week cycles)

Primary Endpoints: Response rate, progression-free survival, safety

Study Characteristics:

• Median age: 62 years
• 23 male, 6 female patients
• Median tumor size: 11.1 cm (range 1.8-16.2 cm)

Efficacy Results

Tumor Response (n=28 evaluable):

• ≥10% shrinkage: 39.3% (n=11)
• Partial response: 25% (n=7)
• Stable disease: 35.7% (n=10)
• Progressive disease: 39.3% (n=11)

Surgical Outcomes:

• 15 patients underwent surgery post-treatment
• 5 demonstrated pathological response

Median PFS: 13.4 months

Safety Profile

Most Common Adverse Events:

• Hepatitis: 48.3%
• Grade 3-4 toxicities: hepatitis (5), infection (2), lipase elevation (2), pruritus (1), leukopenia (1), non-infectious pneumonitis (1)

Clinical Conclusions

Dual checkpoint blockade demonstrates high feasibility as neoadjuvant therapy for resectable advanced HCC. Long-term validation required to determine establishment as standard treatment approach.

Data Source

https://www.annalsofoncology.org/article/S0923-7534(21)01368-5/fulltext

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