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The Optimal Radioimmunotherapy Combinations for Advanced TNBC

NCT06735131 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-03

No results posted yet for this study

Summary

This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).

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)

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2026-07-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06735131 on ClinicalTrials.gov