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Pembrolizumab Plus Lenvatinib in Stage III-IV RCC

4. august 2022 oppdatert av: Tianjin Medical University Second Hospital

A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cance

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery.

Studieoversikt

Status

Rekruttering

Detaljert beskrivelse

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation.Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery. The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.

Studietype

Intervensjonell

Registrering (Forventet)

20

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Tianjin
      • Tianjin, Tianjin, Kina, 300211
        • Rekruttering
        • Changyi Quan

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 til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Age ≥ 18 years and age ≤75years
  3. Patients with pathologically and radiographically confirmed renal cell carcinoma: Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage)
  4. Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery
  5. There are no suspected brain metastases
  6. The presence of measurable lesions was assessed according to RECISTv1.1 criteria
  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  8. Organ function level must meet the following requirements:

    Hematological indexes: neutrophil count >= 1.5x10^9/L, platelet count >= 100x10^9/L, hemoglobin >= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin <=1.5 ULN, alanine aminotransferase and aspartate aminotransferase <=1.5 ULN

  9. Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study
  10. The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up

Exclusion Criteria:

  1. Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors
  2. Previous or concurrent other malignancy
  3. Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1
  4. History of primary immunodeficiency
  5. Active, known or suspected autoimmune diseases
  6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  7. Pregnant or lactating female patients;
  8. Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
  9. Have a clear history of active tuberculosis;
  10. Participating in other clinical researchers;
  11. Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
  12. Uncontrolled concurrent diseases, including but not limited to:

HIV infected (HIV antibody positive); Severe infection in active stage or poorly controlled; Evidence of serious or uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension [i.e. hypertension greater than or equal to CTCAE grade 2 after drug treatment]); Patients with active bleeding or new thrombotic disease

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: Advanced Renal Cell
Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation and patients need to continue taking the drug for a year after surgery.
Pembrolizumab plus Lenvatinib

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ORR
Tidsramme: through study completion, an average of 3 year
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time
through study completion, an average of 3 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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)

1. juli 2022

Primær fullføring (Forventet)

31. desember 2023

Studiet fullført (Forventet)

31. desember 2024

Datoer for studieregistrering

Først innsendt

25. juli 2022

Først innsendt som oppfylte QC-kriteriene

2. august 2022

Først lagt ut (Faktiske)

3. august 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2022

Sist bekreftet

1. august 2022

Mer informasjon

Begreper knyttet til denne studien

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. .

Abonnere