A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Envafolimab+Lenvatinib
DrugTo evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Envafolimab+LenvatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR of liver lesions
Objective Response Rate (ORR) of liver lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame
2 yearsSecondary outcomes
1
DCR of liver lesions
DCR of liver lesions
Time frame
2 years2
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Time frame
2 years3
1-year Overall Survival (OS) rate
1-year Overall Survival (OS) rate
Time frame
2 yearsLocations
Sponsors and contacts
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Fudan University
Lead sponsor
Huadong Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: