- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Beijng
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Beijing, Beijng, Kina, 100191
- Peking University 3rd Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
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 |
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Eksperimentel: 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.
Andre navne:
Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
Andre navne:
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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Aktiv komparator: 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
Andre navne:
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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3-year progression-free survival (PFS)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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3-year overall survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
- M2020411
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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