- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04678791
Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma
To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beijng
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Beijing, Beijng, Cina, 100191
- Peking University 3rd 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:
- Aged 18-75 years old;
- Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- At least one measurable lesion according to RECIST 1.1;
Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria:
Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 2 × 109/L or white blood cell count ≥ 4.0 × 109/L; Platelet count ≥ 100 × 109/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
- ECOG score 0-2 points;
- Expected survival ≥ 3 months;
- Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation);
- No intrauterine device;
- Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
- Compliance is good and informed consent is voluntarily signed.
Exclusion Criteria:
- Cervical adenocarcinoma and rare pathological types of malignant tumors;
- Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- Pregnant or lactating women;
- Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
- Human immunodeficiency virus (HIV) infection;
- Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);
- Patients have a serious underlying condition that precludes safe administration of trial treatment. Including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (NYHA Class III and IV), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment;
- Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
- Patients with Crohn's disease and ulcerative colitis;
- Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
- Patients with known hypersensitivity to Nimotuzumab or its components;
- Patients with contraindications to cisplatin;
- Patients with neurological or psychiatric disorders affecting cognitive ability;
- Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;
- Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
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Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
Altri nomi:
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
Altri nomi:
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.
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Comparatore attivo: Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
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Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
Altri nomi:
Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
3-year progression-free survival (PFS)
Lasso di tempo: up to 3 years
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The rate of patient without progress disease in 3 years after treatment
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up to 3 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
3-year overall survival (OS)
Lasso di tempo: up to 3 years
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The rate of patient alive in 3 years after treatment
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up to 3 years
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Complete response rate (CRR)
Lasso di tempo: 3 months later after treatment
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Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression.
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3 months later after treatment
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Objective response rate (ORR)
Lasso di tempo: 3 months later after treatment
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The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
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3 months later after treatment
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Incidence and severity of acute adverse events
Lasso di tempo: up to 3 months complete treatment
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Number and grade of participants with adverse events
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up to 3 months complete treatment
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
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
Altri numeri di identificazione dello studio
- M2020411
Piano per i dati dei singoli partecipanti (IPD)
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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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YM BioSciencesCIMYM BioSciencesTerminatoCarcinoma polmonare non a piccole cellule metastaticoStati Uniti, Corea, Repubblica di, Canada, Cuba, Pakistan
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Health Science Center of Xi'an Jiaotong UniversityReclutamento
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The First Affiliated Hospital of Zhengzhou UniversityNon ancora reclutamentoCarcinoma a cellule squamose dell'esofagoCina
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National Institute of CancerologíaNational Heart Institute, Mexico; Pisa S.A de C.VCompletatoTrattamento palliativo | Cancro cervicale ricorrente o persistente | Anticorpo monoclonale nel trattamento del cancro cervicaleMessico