NCT07161791Toborzás még nem indult1/2. fázis
Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 9. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This is a prospective, single-arm, exploratory clinical study, planned to enroll 12 patients with advanced triple-negative breast cancer who have received first-line systemic treatment with immune checkpoint inhibitors. The treatment regimen will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator's judgment that treatment must be terminated. Imaging assessment will be performed according to RECIST 1.1 criteria, with the research center's assessment results as the final outcome. Subjects who discontinue treatment will enter the follow-up period: 1) Safety follow-up until 30 days after the last dose; 2) Subjects who discontinue treatment for reasons other than progression disease (PD) or death will undergo efficacy follow-up until disease progression, initiation of other anti-tumor drugs, or death, whichever comes first; 3) All subjects will enter the trial period upon enrollment and receive camrelizumab combined with pirfenidone and chemotherapy.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 12 (tervezett)
- Első benyújtás
- 2025. aug. 15.
- Kezdés
- 2025. szept. 15.
- Elsődleges befejezés
- 2026. dec. 31.
- Fő szponzor
- Harbin Medical University
- Betegségek
- Tripla negatív emlőrák
- NCT-szám
- NCT07161791
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 12
- 2025. szept. 15. és az elsődleges befejezés (2026. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Concurrent participation in another interventional cancer trial.
- Received other antitumor therapy within 14 days before first dose.
- Prior treatment with pirfenidone.
- Major non-breast cancer surgery within 4 weeks prior to enrollment or incomplete recovery from such surgery.
- Live vaccination within 4 weeks before or during study.
- Severe concomitant disease or condition that may interfere with study participation per investigator judgment
Más betegség
- Untreated active brain metastases or leptomeningeal disease.
- Active or history of autoimmune disease (except vitiligo, resolved childhood asthma without treatment in adulthood).
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Known allergy to study drugs or excipients.
Laborértékek
- Severe cardiac disease (e.g., heart failure with LVEF <50%, uncontrolled arrhythmias, angina requiring medication, significant valvular disease, recent myocardial infarction, poorly controlled hypertension >180/100 mmHg).
Kiket keres a vizsgálat
- Female, aged 18-70 years.
- Histologically confirmed recurrent/metastatic TNBC (ER-negative: IHC ER <1%; PR-negative: IHC PR <1%; HER2-negative: IHC -/+, or IHC ++ but FISH/CISH negative), with at least one measurable lesion per RECIST v1.1.
- ECOG performance status 0-2.
- Estimated life expectancy ≥3 months.
- Received first-line chemotherapy + PD-1/PD-L1 inhibitor for metastatic or locally advanced unresectable TNBC, with response of CR/PR or stable disease lasting ≥3 months. For neoadjuvant/adjuvant therapy, disease progression during treatment or within 6 months after completion will be considered as first-line failure.
- Adequate organ function (no transfusion, growth factor, or thrombopoietic agents within 2 weeks before screening):
- Hematology: ANC ≥1.5×10⁹/L; PLT ≥90×10⁹/L; Hb ≥90 g/L.
- Serum chemistry: TBIL ≤1.5×ULN; ALT and AST ≤1.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL/min (Cockcroft-Gault).
- TSH ≤ULN (if abnormal, T3 and T4 must be assessed; enrollment allowed if T3/T4 normal).
- Cardiac: LVEF ≥50% by echocardiography; 18-lead ECG with QTcF <480 ms (female).
- Women of childbearing potential must have negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use adequate contraception during treatment and for 4 months after last dose.
- Voluntarily signed informed consent and good compliance.
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.