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Trial Title:
Neoadjuvant Immune-based Combinations in Patients Undergoing Nephrectomy for Locally Advanced ccRCC
NCT ID:
NCT06114940
Condition:
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Carcinoma
Carcinoma, Renal Cell
Antineoplastic Agents
Immune Checkpoint Inhibitors
Conditions: Official terms:
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Urogenital Diseases
Male Urogenital Diseases
Female Urogenital Diseases
Lenvatinib
Conditions: Keywords:
ccRCC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240mg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses
prior to partial nephrectomy or radical nephrectomy
Arm group label:
Experimental group
Other name:
anti-PD-1 monoclonal antibody
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
18 mg by mouth once each day for 12 weeks prior to nephrectomy
Arm group label:
Experimental group
Other name:
Lenvatinib mesylate (USAN)
Summary:
The objective of this single-center clinical trial was to evaluate the objective response
rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib)
in neoadjuvant treatment of（T2a-T4NanyM0 or TanyN1M0） clear cell renal cell carcinoma.
Detailed description:
The objective of this single-center clinical trial was to evaluate the objective response
rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib)
in neoadjuvant treatment of（T2a-T4NanyM0 or TanyN1M0） clear cell renal cell
carcinoma.Toripalimab is a new antibody that may help activate the immune system by
blocking the function of the inhibitory molecule PD-1. This is a single-institution,
single-arm Phase 2 clinical trial. Patients will be treated with Toripalimab in
combination with tyrosine kinase inhibitors TKI (Lenvatinib) and patients will undergo
partial or radical nephrectomy after neoadjuvant therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Imaging is consistent with（T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma
- Puncture pathological biopsy was consistent with clear cell renal cell carcinoma
- Subjects were to undergo radical nephrectomy or partial nephrectomy or enucleation
of renal tumor
- ECOG 0-1 points -Normal hematopoietic and organ function --
- Understand and plan visits, treatments, laboratory tests, and other research
procedures.
Exclusion Criteria:
- Prior systemic anti-tumor treatment for RCC
- Patients who are receiving any other investigational agents.
- Clinical status indicating that immediate surgery (within 6 weeks) iswarranted
regardless of whether neoadjuvant therapy is to beadministered, as assessed by the
treating surgeon.
- Inability to undergo baseline tumor biopsy.
- Active or prior documented autoimmune or immunocompromisingconditions.
- Uncontrolled hypertension
- In the investigator's judgment, the subject has a medical history or current
evidence of any disease, treatment, or laboratory abnormality that could confuse the
results of the trial, interfere with the subject's participation throughout the
trial, or is not in the subject's best interest to participate in the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Le Qu, M.D.
Phone:
15720625951
Email:
septsoul@hotmail.com
Start date:
December 20, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06114940
