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RECRUITING
NCT06735131
PHASE2

The Optimal Radioimmunotherapy Combinations for Advanced TNBC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

RADIATION

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

RADIATION

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

RADIATION

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

RADIATION

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

RADIATION

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)

DRUG

Toripalimab

Toripalimab (240 mg IV, d1, Q3W)

DRUG

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