- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05485896
Pembrolizumab Plus Lenvatinib in Stage III-IV RCC
A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cance
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Tianjin
-
Tianjin, Tianjin, Kina, 300211
- Rekruttering
- Changyi Quan
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Willing and able to provide written informed consent
- Age ≥ 18 years and age ≤75years
- Patients with pathologically and radiographically confirmed renal cell carcinoma: Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage)
- Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery
- There are no suspected brain metastases
- The presence of measurable lesions was assessed according to RECISTv1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
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
- 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
- The subjects volunteered to join the study, signed informed consent, and had good compliance with follow-up
Exclusion Criteria:
- Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors
- Previous or concurrent other malignancy
- Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1
- History of primary immunodeficiency
- Active, known or suspected autoimmune diseases
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Pregnant or lactating female patients;
- 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;
- Have a clear history of active tuberculosis;
- Participating in other clinical researchers;
- Men with reproductive capacity or women who are likely to become pregnant do not take reliable contraceptive measures;
- 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
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
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Nyre-neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Proteinkinasehemmere
- Pembrolizumab
- Lenvatinib
Andre studie-ID-numre
- PELUR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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