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The Optimal Radioimmunotherapy Combinations for Advanced TNBC
Sponsor: Sun Yat-sen University
Summary
This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).
Official title: A Prospective, Multicenter Clinical Trial Exploring the Optimal Combination Strategies of Radiotherapy and Immunotherapy for Advanced Triple-Negative Breast Cancer
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-12-20
Completion Date
2027-01
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
radiotherapy 5 Gy × 5 fractions, once a day
5 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 8 Gy × 5 fractions, once a day
8 Gy × 5 fractions, once a day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 8 Gy × 3 fractions, once every other day
8 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotherapy 10 Gy× 3 fractions, once every other day
10 Gy × 3 fractions, once every other day, beginning on the day within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
radiotehrapy 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (total 8Gy)
0.5 Gy twice-a-day × 2 days, on the first 2 days of the first 4 cycles of toripalimab and chemotherapy (total 8Gy)
Toripalimab
Toripalimab (240 mg IV, d1, Q3W)
chemotherapy regimen selected by the investigator
Regimens to be selected from: (1) Nab-paclitaxel (125 mg/m2 IV, days 1, 8, Q3W) (2) Gemcitabine (1000 mg/m² IV, days 1 and 8, Q3W) + carboplatin (AUC=2 IV, days 1 and 8, Q3W)
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China