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"Phase II study of ceralasertib (AZD6738) in combination with durvalumab in patients with advanced gastric cancer"* into a more structured format:
Abstract
Introduction
This study explores the efficacy and safety of combining ceralasertib (AZD6738) with durvalumab in advanced gastric cancer patients.
Methods
- Design: Open-label, single-center, non-randomized, phase II clinical trial.
- Treatment: Patients received ceralasertib (240 mg twice daily, days 15-28) with durvalumab (1500 mg, day 1 every 4 weeks).
- Endpoints: Primary endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results
- Participants: 53 patients enrolled.
- ORR: 22.6%.
- DCR: 58.1%.
- PFS: Median of 3.0 months.
- OS: Median of 6.7 months.
- Safety: Adverse events were manageable with dose modifications.
Biomarker Analysis
- Findings: Subgroup with loss of ATM expression and high HRD showed longer PFS.
- Immune Response: Upregulation of innate immune response and activation of intratumoral lymphocytes in responders.
Conclusion
The combination of ceralasertib and durvalumab demonstrated clinical activity and manageable safety in advanced gastric cancer, particularly benefiting patients with specific biomarker profiles
Original text
"Phase II study of ceralasertib (AZD6738) in combination with durvalumab in patients with advanced gastric cancer"* into a more structured format:
Abstract
Introduction
This study explores the efficacy and safety of combining ceralasertib (AZD6738) with durvalumab in advanced gastric cancer patients.
Methods
- Design: Open-label, single-center, non-randomized, phase II clinical trial.
- Treatment: Patients received ceralasertib (240 mg twice daily, days 15-28) with durvalumab (1500 mg, day 1 every 4 weeks).
- Endpoints: Primary endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.
Results
- Participants: 53 patients enrolled.
- ORR: 22.6%.
- DCR: 58.1%.
- PFS: Median of 3.0 months.
- OS: Median of 6.7 months.
- Safety: Adverse events were manageable with dose modifications.
Biomarker Analysis
- Findings: Subgroup with loss of ATM expression and high HRD showed longer PFS.
- Immune Response: Upregulation of innate immune response and activation of intratumoral lymphocytes in responders.
Conclusion
The combination of ceralasertib and durvalumab demonstrated clinical activity and manageable safety in advanced gastric cancer, particularly benefiting patients with specific biomarker profiles
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