- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04766827
Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor
A Prospective Randomized Controlled Clinical Study of Albumin-bound Paclitaxel Combined With Cisplatin (AP Regimen) Versus Docetaxel Combined With Cisplatin (TP Regimen) Induced Chemotherapy in Advanced Head and Neck Squamous Tummor
Research Topic:
A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma
Expected study duration:
Each subject received a 3-week regimen of AP or TP over 2 cycles.
Research objectives:
To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared.
Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Research purposes:Research the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma were evaluated,by comparing the AP regimen and the TP regimen .
Research content:To evaluate the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.
Study endpoint Primary endpoint: Objective response rate (ORR=CR+PR) (Assessed according to RECIST standards, see Annex 1) Secondary study endpoint: Surgical resection rate,Pathological remission rate,Progression-free survival (PFS), Overall survival (OS) Main safety indicators: Observe any adverse events that occurred in all subjects during the clinical study and within 1 month after stopping the drug, including clinical symptoms, abnormal vital signs, and abnormalities in laboratory examinations, and record their clinical features, Severity, time of occurrence, duration, treatment method and prognosis outcome, and determine its correlation with the study drug. The safety of the drug was evaluated according to the NCI-CTC AE 4.0 standard.
Study design:This is a single-center, open-label, controlled clinical study.The aime is observing and evaluating the effectiveness and safety of albumin-bound paclitaxel for induction chemotherapy in patients with advanced head and neck squamous cell carcinoma.
This study is planned to be carried out in Tianjin Cancer Hospital. According to the research principles of GCP.
The study plans to recruit 116 qualified subjects. This study used objective response rate (ORR=CR+PR) as the main evaluation index. According to previous reports, the ORR of the TP group was 50%, and the ORR of the AP group was estimated to be 75%. The test level is set to 0.05 on one side, the test power is set to 0.8, and the estimated dropout rate is 20%. Using the Logrank-Lakatos algorithm, the total sample size is calculated to be 116 cases.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Tianjin
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Tianjin, Tianjin, Cina, 300000
- Reclutamento
- Tianjin Medical University Cancer Institute and Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Inclusion criteria:
- Age ≥18 years old, male or female;
- Subjects had squamous cell carcinoma of the head and neck confirmed by histrohistology or cytology;
- CLINICAL STAGE III OR IV WITHOUT DISTANT METASTASES (AJCC 8th)
- Patients who have not previously received initial treatment with chemotherapy or radiation;
- KPS acuity 70;
- Normal bone marrow reserve function and normal liver and kidney function;
- Expected survival time ≥3 months;
- Subjects of child-bearing age must agree to use effective contraceptive measures during the study period; The serum or urine pregnancy test must be negative for women of childbearing age 72 hours before the start of chemotherapy;
- Subjects have good compliance, can carry out treatment and follow-up, and voluntarily abide by the regulations of this study;
- Subjects voluntarily sign the informed consent.
Exclusion Criteria:
Exclusion criteria:
- Patients with distant metastasis;
- The presence of uncontrolled serious medical diseases, such as combined with serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- The presence of dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or filling out questionnaires;
- Subjects with grade ≥2 peripheral neuropathy according to CTCAE V5.0;
- A history of allergy or hypersensitivity to any therapeutic ingredient;
- Suffered from malignant tumors other than squamous cell carcinoma of the head and neck in the past 5 years, except adequately treated basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
Abnormal results of physical and laboratory tests:
A) Hematologic abnormalities are defined as:
I) Absolute count of neutrophils (ANC) : < 1.5×109 / L; Ii) Platelet (PLT) count: < 100×109/L; Iii) Hemoglobin (Hb) level < 90g/L;
B) Abnormal liver function is defined as:
I) Total bilirubin (TBIL) level: 1.5 times of the upper limit of normal value of > (ULN); Ii) AST and ALT levels of >ULN were 2.5 times, and BBB>N was 5 times if liver metastasis was present;
C) Definition of abnormal renal function:
1.5 times of serum creatinine > ULN, or the calculated creatinine clearance rate < 50ml/min;
- Patients who need to be treated with other anti-tumor drugs;
- Has received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
- The researcher considers it unsuitable for inclusion;
- Pregnant or lactating women.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: albumin-bound paclitaxel combined with cisplatin (AP regimen)
Paclitaxel (albumin combined type) 260 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; Cisplatin: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles;
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Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
Altri nomi:
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Comparatore attivo: docetaxel combined with cisplatin (TP regimen)
docetaxel: 75 mg/m2, intravenous drip, d1, every three weeks for a cycle, a total of dosing 2 cycles; cisplatin: 75 mg/m2, d1 every three weeks for a cycle, a total of dosing 2 cycles;
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Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Objective response rate
Lasso di tempo: 21 days
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ORR=CR+PR
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21 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sistema operativo
Lasso di tempo: 5 anni
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sopravvivenza globale
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5 anni
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Surgical resection rate
Lasso di tempo: 1 month
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the rate of Surgical resection in all samples
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1 month
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pathological response rate
Lasso di tempo: 1 month
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the rate of pathological response in all samples
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1 month
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PFS
Lasso di tempo: 5 year
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progression-free survival
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5 year
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidenza di eventi avversi
Lasso di tempo: 90 giorni
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Incidenza di eventi avversi
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90 giorni
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Xudong Wang, MD, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie della testa e del collo
- Carcinoma, cellule squamose
- Carcinoma a cellule squamose della testa e del collo
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Docetaxel
- Paclitaxel
- Paclitaxel legato all'albumina
Altri numeri di identificazione dello studio
- TJCIHMF&ENT-001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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