Resectable Advanced HCC: Neoadjuvant Dual Checkpoint Immunotherapy
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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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