- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05311566
PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer
5. april 2022 oppdatert av: Lei Li
Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study
This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer.
Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol.
Subjects who finished treatment entered the safety follow-up or survival follow-up.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
92
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Beijing
-
Beijing, Beijing, Kina, 100730
- Rekruttering
- Lei Li
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB;
- Have not received radiotherapy, chemoradiotherapy or other'system therapy for,cervical,cancer in the past.
- With measurable tumor lesions (meet RECIST 1.1 standard).
- Age≥18 years old when signing the informed consent, female.
- ECOG PS: 0-2 points.
- Expected survival time > 6 months.
- According with lab testing criteria in the protocol.
- Ability and willingness to comply with research and follow-up procedures.
- Females of childbearing potential must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.
- The patients voluntarily joined the clinical study and signed the informed consent, with good compliance and follow-up.
Exclusion Criteria:
- Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cell costimulation or checkpoint pathways);
- Have a clear history of allergies, and may have potential allergies or intolerances to the study drug and its similar biological agents.
- Participated in clinical trials of other antitumor drugs within 4 weeks before the first dose, or planned to receive live attenuated vaccines within 4 weeks before the first dose or during the study.
- Other malignant tumors have occurred within 5 years (except for adequately treated cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
- Use immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (no more than 10 mg/day prednisolone or other corticosteroids at equivalent doses),within 14 days of first use of camrelizumab.
- Symptomatic advanced patients with visceral dissemination who are at short-term risk of life-threatening complications (including uncontrolled massive exudates [thoracic, pericardium, abdominal], pulmonary lymphangitis and more than 30% patients with liver involvement).
- Presence or history of any active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, no need for any after adulthood Asthma patients who need bronchodilator for medical intervention can not be included).
- Subjects with grade II or higher myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the New York Heart Association standard, Subjects with grade III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection fraction (LVEF) <50%; myocardial infarction occurred within 6 months before enrollment, and New York Heart Association grade II or above cardiac function Failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or active conduction system abnormalities.
- Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, or antivirals) within 4 weeks prior to first dose, or unexplained fever >38.5°C during screening or before first dose.
- Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and C.
- Subjects with untreated central nervous system metastases, Subjects who have received systemic, radical brain or meningeal metastases in the past (radiotherapy or surgery), have been stable for at least 1 month if confirmed by imaging, and have stopped systemic hormone therapy (Dose > 10mg/day prednisone or other equivalent therapeutic hormones) for more than 2 weeks and without clinical symptoms can be included.
- Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction (the investigator will determine whether they can be included).
- Other conditions not considered suitable for inclusion by the researcher.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Patients with primary IB2-IIIB cervical cancer
Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
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Participants will be given intravenous administration of Camrelizumab (200mg,every 2 weeks),Cisplatin(40mg/m²,everyweek) and Radiotherapy.
After completing 6~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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3-year OS rate
Tidsramme: 36 months
|
Patient proportion to survival in the third year
|
36 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival(PFS)
Tidsramme: 24 months
|
The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs.
|
24 months
|
|
Objective response rate (ORR)
Tidsramme: 12 months
|
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission(CR) and partial remission(PR).
|
12 months
|
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Acute Adverse Events (AEs)
Tidsramme: 36 months
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The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0
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36 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. mars 2022
Primær fullføring (Forventet)
27. mars 2023
Studiet fullført (Forventet)
27. mars 2026
Datoer for studieregistrering
Først innsendt
27. mars 2022
Først innsendt som oppfylte QC-kriteriene
27. mars 2022
Først lagt ut (Faktiske)
5. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IMURADIO3
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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