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PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

5 april 2022 bijgewerkt door: 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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Verwacht)

92

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Beijing
      • Beijing, Beijing, China, 100730
        • Werving
        • Lei Li

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  1. Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB;
  2. Have not received radiotherapy, chemoradiotherapy or other'system therapy for,cervical,cancer in the past.
  3. With measurable tumor lesions (meet RECIST 1.1 standard).
  4. Age≥18 years old when signing the informed consent, female.
  5. ECOG PS: 0-2 points.
  6. Expected survival time > 6 months.
  7. According with lab testing criteria in the protocol.
  8. Ability and willingness to comply with research and follow-up procedures.
  9. Females of childbearing potential must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.
  10. The patients voluntarily joined the clinical study and signed the informed consent, with good compliance and follow-up.

Exclusion Criteria:

  1. 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);
  2. Have a clear history of allergies, and may have potential allergies or intolerances to the study drug and its similar biological agents.
  3. 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.
  4. Other malignant tumors have occurred within 5 years (except for adequately treated cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
  5. 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.
  6. 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).
  7. 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).
  8. 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.
  9. 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.
  10. Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders.
  11. 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.
  12. 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.
  13. Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction (the investigator will determine whether they can be included).
  14. Other conditions not considered suitable for inclusion by the researcher.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Patients with primary IB2-IIIB cervical cancer
Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
3-year OS rate
Tijdsspanne: 36 months
Patient proportion to survival in the third year
36 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival(PFS)
Tijdsspanne: 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)
Tijdsspanne: 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
Acute Adverse Events (AEs)
Tijdsspanne: 36 months
The number of participants who experience unacceptable toxicity during protocol treatment as measured by the NCI CTCAE version 5.0
36 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

27 maart 2022

Primaire voltooiing (Verwacht)

27 maart 2023

Studie voltooiing (Verwacht)

27 maart 2026

Studieregistratiedata

Eerst ingediend

27 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

27 maart 2022

Eerst geplaatst (Werkelijk)

5 april 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 april 2022

Laatste update ingediend die voldeed aan QC-criteria

5 april 2022

Laatst geverifieerd

1 april 2022

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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