The Optimal Radioimmunotherapy Combinations for Advanced TNBC
NCT ID: NCT06735131
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-12-20
2027-01-31
Brief Summary
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Detailed Description
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Recently, the advent of immune checkpoint inhibitors has offered new therapeutic prospects for mTNBC. Inhibitors of PD-1/PD-L1, such as Pembrolizumab, Atezolizumab, and Toripalimab, have demonstrated some effectiveness in clinical trials, especially in patients with PD-L1-positive tumors. Yet, the overall response to immunotherapy remains low, and there is a risk of immune-related adverse events (irAEs), which require vigilant monitoring.
To address the shortcomings of both chemotherapy and immunotherapy, researchers are investigating innovative treatment strategies. These include targeting additional immune checkpoint molecules within the tumor microenvironment, developing novel chemotherapy drugs, and integrating immunotherapy with other treatments like radiotherapy. Local radiotherapy can substantially stimulate the immune system, increasing the antigenicity of cancer cells and enhancing the ability of cytotoxic T lymphocytes to recognize and attack cancer cells.
Although combined radiotherapy and immunotherapy have shown promise in treating other types of cancer, the most effective combination patterns, optimal radiotherapy dosing schedules, and the most suitable patient groups for advanced breast cancer, particularly mTNBC, are not well defined. This study seeks to identify the best combinations of radiotherapy and immunotherapy for advanced breast cancer, with the aim of improving survival rates and setting new standards for treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: 5Gy × 5 , daily
within 4 weeks before the initiation of cycle of toripalimab and chemotherapy
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
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)
Arm 2: 8Gy × 5 , daily
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
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)
Arm 3: 8Gy × 3, every other 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
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)
Arm 4: 10Gy × 3, every other 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
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)
Arm 5: 0.5Gy twice-a-day × 2 days, repeat for 4 cycles (8 Gy in total)
on the first 2 days of first 4 cycles 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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
2. No prior chemotherapy for advanced/metastatic disease.
3. ECOG PS score of 0 or 1.
4. Presence of 1 to 5 tumor lesions suitable for radiotherapy (individual lesion size between 0.5 and 5 cm, not limited to 1 to 2 organs).
5. At least one measurable lesion outside the radiation field that can be evaluated.
6. Suitable to receive one of the chemotherapy regimens chosen by the investigator: nab-paclitaxel or gemcitabine + carboplatin.
7. Patients with brain metastases are allowed if they do not require local therapy at enrollment or if the metastatic lesion is treated with the assigned radiotherapy regimen.
8. Patients who have previously received PD-1/PD-L1 therapy for early-stage disease are allowed to enroll.
9. Able to provide tumor tissue sections or agree to tumor biopsy during the screening period.
10. Adequate organ and bone marrow function, with specific requirements:
1. Hematology: Neutrophil count (ANC) ≥1.5×10\^9/L; Platelet count (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥90 g/L; No blood product transfusion (including red blood cell and platelet products, etc.) or growth factor (including colony-stimulating factors, interleukins, and erythropoietin, etc.) support treatment within 2 weeks prior to examination.
2. Liver function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastases: ALT and AST ≤5×ULN).
3. Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance \>60 mL/min.
Exclusion Criteria
2. Have received radiotherapy within 12 weeks prior to enrollment, unless the radiotherapy was for adjuvant purposes and there are lesions outside the previously irradiated field.
3. Extensive tumor metastasis with surrounding normal tissues that cannot tolerate radiotherapy damage.
4. Significant third-space fluid retention (e.g., ascites, pleural effusion, pericardial effusion).
5. Require long-term systemic corticosteroid treatment.
6. Have active autoimmune diseases.
7. Have concurrent severe infections.
8. Other patients deemed unsuitable for enrollment by the investigator.
ALL
No
Sponsors
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West China Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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wang shusen
Professor
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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SYSUCC-025
Identifier Type: -
Identifier Source: org_study_id
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