The Optimal Radioimmunotherapy Combinations for Advanced TNBC

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 20, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

January 31, 2027

Conditions
Triple-Negative Breast Cancer (TNBC)
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)

Trial Locations (1)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

West China Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

lead

Sun Yat-sen University

OTHER