Clinical trial NCT06129955: Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Pucotenlimab
Lenvatinib
Non-clear renal cell carcinoma
Neoadjuvant therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Eligibility criteria: 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):

1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L (1,500/mm\^3);
2. Platelet count (PLT) ≥ 100×10\^9/L (100,000/mm\^3);
3. Hemoglobin (HB) ≥ 90 g/L.

Hepatic function:

1. Total bilirubin (TBIL) ≤ 1.5×ULN;
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; for subjects with liver metastasis, AST and ALT ≤ 5×ULN.
3. 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.

Primary outcomes:
measure: ORR
timeFrame: At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Other (Non U.s.)
Study officials:
References: