Status:
UNKNOWN
Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized rena...
Detailed Description
Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized rena...
Eligibility Criteria
Inclusion
- Voluntary signing of a written Informed Consent Form (ICF).
- Age ≥18 and \<80 years at the time of enrollment, regardless of gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥3 months.
- Preoperative biopsy confirming non-clear cell renal cancer.
- Patient's willingness to undergo nephron-sparing surgery.
- Have indications for nephron-sparing surgery but with high difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
- At least one measurable lesion (according to mRECIST v1.1 criteria) suitable for repeated and accurate measurements.
- Good organ function, with screening laboratory results meeting the following criteria:
- Hematology (no blood component or growth factor support therapy in the two weeks before treatment):
- Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (1,500/mm\^3);
- Platelet count (PLT) ≥ 100×10\^9/L (100,000/mm\^3);
- Hemoglobin (HB) ≥ 90 g/L.
- Hepatic function:
- Total bilirubin (TBIL) ≤ 1.5×ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; for subjects with liver metastasis, AST and ALT ≤ 5×ULN.
- Serum albumin (ALB) ≥ 28g/L.
- Coagulation function:
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- · Willingness and ability of the subject to comply with the scheduled visits, treatment plan, laboratory tests, and other study requirements.
Exclusion
- Renal biopsy pathology diagnosis indicates collecting duct carcinoma.
- Renal biopsy pathology diagnosis indicates chromophobe carcinoma.
- Renal biopsy pathology indicates clear cell renal cell carcinoma or predominantly clear cell renal cell carcinoma.
- Presence of lymph node metastasis.
- Tumor encases the renal artery.
- Intravascular tumor thrombus in the renal vein.
- Tumor exhibits diffuse growth without distinct boundaries from normal renal parenchyma.
- Poor general condition, unsuitable for tolerating general anesthesia surgery in anesthesia assessment.
- Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, and diabetes.
- Patients using long-term immunosuppressive agents after organ transplantation.
- Patients currently using immunosuppressive drugs.
- Patients with evident infection or fever.
- Patients with T-cell lymphoma, myeloma.
- Simultaneously having other malignant tumors, undergoing treatment for malignancies, or having a history of other malignant tumors within the past six months.
- Metastatic renal cell carcinoma.
- Received herbal or immune-modulating drugs with antitumor indications within 14 days before the first use of the investigational drug.
- Undergoing systemic therapy (excluding thoracoscopic peptide, interferon, interleukin used for controlling pleural effusion locally).
- Active or potential relapse of autoimmune diseases, except for cases not requiring systemic treatment such as stable vitiligo, alopecia, psoriasis, or eczema; hypothyroidism caused by autoimmune thyroiditis that requires stable hormone replacement therapy; Type I diabetes requiring stable insulin replacement therapy.
- Concurrent participation in another clinical study unless it is an observational, non-interventional clinical study, or the follow-up period of an interventional study.
- Known mental illness, substance abuse, alcoholism, or drug addiction history.
- Pregnant or lactating women.
- Past or current existence of any diseases, treatments, or laboratory abnormalities that might confound study results, affect the subject's full participation in the study, or participation that may not be in the subject's best interest.
Key Trial Info
Start Date :
November 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06129955
Start Date
November 11 2023
End Date
December 31 2025
Last Update
November 13 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), China, 0755