Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129955

Collaborator

(none)

Enrollment

Location

Arm

25.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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 renal cancer, who have indications for nephron-sparing surgery but face significant difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: Pucotenlimab Combined With Lenvatinib	Phase 2

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

47 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Clinical Study on the Efficacy and Safety of Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma With Indications for Partial Nephrectomy But High Surgical Risk: A Single Arm Approach

Anticipated Study Start Date :

Nov 11, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pucotenlimab combined with Lenvatinib as neoadjuvant therapy Pucotenlimab combined with Lenvatinib as neoadjuvant therapy	Drug: Pucotenlimab Combined With Lenvatinib Patients treated by Pucotenlimab combined with Lenvatinib for 3 months before surgery

Arm

Intervention/Treatment

Experimental: Pucotenlimab combined with Lenvatinib as neoadjuvant therapy

Pucotenlimab combined with Lenvatinib as neoadjuvant therapy

Drug: Pucotenlimab Combined With Lenvatinib

Patients treated by Pucotenlimab combined with Lenvatinib for 3 months before surgery

Outcome Measures

Primary Outcome Measures

ORR [At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment]
Objective Response Rate (ORR) based on RECIST 1.1 criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.