- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04952493
Anlotinib or Penpulimab in Combination With RAI for DTC
18. januar 2022 oppdatert av: Yansong Lin, Peking Union Medical College Hospital
The Efficacy and Safety of Anlotinib Hydrochloride or Penpulimab In Combination With RAI in Patients With Local Advanced or Metastatic Differentiated Thyroid Cancer: A Randomized, Open-label, Exploratory Clinical Trial
The purpose of this study is to assess the efficacy and safety of anlotinib in combination with I-131 in locally advanced/metastatic differentiated thyroid cancer.
Anlotinib may stop the growth of tumor cells and improve iodine uptake.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Primary Outcome Measures:
objective response rate (ORR)
Secondary Outcome Measures:
- Biochemical Response Rate (BRR) Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice
- Disease Control Rate (DCR)
- Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging
Studietype
Intervensjonell
Registrering (Forventet)
42
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yansong Lin, MD
- Telefonnummer: +86-10-69155610
- E-post: linys@pumch.cn
Studiesteder
-
-
-
Beijing, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
-
Ta kontakt med:
- Yan-Song Lin, MD
- Telefonnummer: +86-10-69155610
- E-post: linys@pumch.cn
-
-
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
Alle
Beskrivelse
Inclusion Criteria:
- local advanced or metastatic differentiated thyroid cancer (DTC)
- scheduled to receive RAI treatment.
- absence of good remission of RAI or may not get satisfactory remission from RAI treatment
- At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
- Be 18 years of age or older, ECOG PS: 0-2. Life expectancy of at least 6 months.
- Main organs function is normal.
- The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion Criteria:
- Patients who had previously received treatment with Antiangiogenic tyrosine kinase inhibitors, such as: Anlotinib, apatinib and Lenvatinib.
- Patients who had previously received local treatment within 4 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
- Patients with previous or current concurrent malignancies or solid organs or bone marrow transplants within 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
- Unmitigated ≥ grade 2 toxicity (CTC AE 5.0) due to any prior treatment, excluding alopecia.
- With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- Patients with pleural effusion or ascites.
- Patients with any severe and/or uncontrolled disease.
- Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.
- Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 2 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
- Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: anlotinib + RAI
Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI)
|
Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.
RAI treatment may shrink the tumor
Andre navn:
|
Annen: RAI only
Patients in this arm will receive RAI treatment as scheduled.
|
RAI treatment may shrink the tumor
Andre navn:
|
Eksperimentell: Penpulimab + RAI
Patients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable.
|
RAI treatment may shrink the tumor
Andre navn:
Penpulimab is a novel structure Immune checkpoint inhibitor.
The combination of Penpulimab and RAI might have synergistic effects for DTC.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
objective response rate (ORR)
Tidsramme: up to 24 months
|
Proportion of patients with target lesions reaching PR or CR
|
up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Disease Control Rate (DCR)
Tidsramme: up to 24 months
|
Proportion of patients with target lesions reaching PR, CR or SD
|
up to 24 months
|
Biochemical Response Rate (BRR)
Tidsramme: up to 24 months
|
Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice
|
up to 24 months
|
Progression-free Survival (PFS) (median)
Tidsramme: up to 24 months
|
PFS was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
|
up to 24 months
|
Nuclear medicine functional imaging changes of target lesions
Tidsramme: up to 24 months
|
The dynamic changes of I uptake and 18F-FDG PET/CT imaging
|
up to 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yansong Lin, MD, Peking Union Medical College Hospital
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)
15. september 2021
Primær fullføring (Forventet)
20. juli 2023
Studiet fullført (Forventet)
20. juli 2024
Datoer for studieregistrering
Først innsendt
27. juni 2021
Først innsendt som oppfylte QC-kriteriene
27. juni 2021
Først lagt ut (Faktiske)
7. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. januar 2022
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ALTER-T002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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