En undersøgelse af Camrelizumab Plus kemoterapi i kombination med eller uden famitinib som neoadjuverende terapi hos deltagere med tredobbelt negativ brystkræft (TNBC) (BCTOP-T-N01)
Et randomiseret, åbent, multicenter fase III-studie af Camrelizumab Plus kemoterapi i kombination med eller uden famitinib som neoadjuverende terapi hos deltagere med tredobbelt negativ brystkræft (TNBC)
This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factor: clinical stage of the tumor (stage II; Stage III) . Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy.
Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received surgical treatment, and pathological evaluation of tumor efficacy was performed after surgery.
During the study treatment, if the subjects show disease progression, toxicity intolerance, withdrawal of informed consent, or the investigator determines that medication must be terminated, the study treatment will be terminated, and follow-up will continue, including disease recurrence and metastasis and safety follow-up.
Participants who complete surgical treatment will be followed for at least 2 years for event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), and safety assessment. Safety data should be collected from the signing of the informed consent until 28 days after the end of the study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: chen li, MD
- Telefonnummer: +86-021-64175590
- E-mail: chen_li@fudan.edu.cn
Studiesteder
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-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Breast cancer institute of Fudan University Cancer Hospital
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Kontakt:
- Zhi-Ming Shao, MD
- Telefonnummer: 86-21-641755901105
- E-mail: zhimingshao@yahoo.com
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Kontakt:
- Lei Fan, MD
- Telefonnummer: 86-21-641755901105
- E-mail: cmchen@medmail.com.cn
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Ledende efterforsker:
- Zhi-Ming Shao, MD
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Underforsker:
- Li CHEN, MD
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center Shanghai, China, 200032
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Kontakt:
- Zhimin Shao, M.D.
- Telefonnummer: 88807 +86-021-64175590
- E-mail: zhimingshao@yahoo.com
-
Kontakt:
- Linxiaoxi Ma, M.D
- Telefonnummer: 63169 +86-021-64175590
- E-mail: mary2008white@126.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Inclusion Criteria:
ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study.
Exclusion Criteria:
- Has a history of breast cancer. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or breast-feeding women. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary protein quantity > 1g at 24h;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A
Camrelizumab Plus Chemotherapy and Famitinib |
camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
Andre navne:
|
|
Aktiv komparator: Arm B
Camrelizumab Plus Chemotherapy |
Camrelizumab Plus Chemotherapy |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pathological complete response (pCR) rate
Tidsramme: Up to approximately 24 weeks
|
the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery |
Up to approximately 24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal respondere vurderet ved modificerede responsevalueringskriterier i solide tumorer (RECIST v1.1) for mållæsioner vurderet ved MR.
Tidsramme: Op til cirka 67 uger
|
Op til cirka 67 uger
|
|
|
Event-free Survival (EFS) as assessed by Investigator
Tidsramme: At least 2 years
|
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause. |
At least 2 years
|
|
Disease-free Survival (DFS) as assessed by Investigator
Tidsramme: At least 2 years
|
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause. |
At least 2 years
|
|
Distant Disease-free Survival (DDFS) as assessed by Investigator
Tidsramme: At least 2 years
|
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause. |
At least 2 years
|
|
Objective response rate (ORR) in accordance with RECIST v1.1
Tidsramme: Up to approximately 24 weeks
|
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI. |
Up to approximately 24 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BCTOP-T-N01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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