NCT06129955

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 11, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 6, 2023

Last Update Submit

November 10, 2023

Conditions

Renal Cell Carcinoma

Keywords

PucotenlimabLenvatinibNon-clear renal cell carcinomaNeoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective Response Rate (ORR) based on RECIST 1.1 criteria.

    At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment

Study Arms (1)

Pucotenlimab combined with Lenvatinib as neoadjuvant therapy

EXPERIMENTAL

Pucotenlimab combined with Lenvatinib as neoadjuvant therapy

Drug: Pucotenlimab Combined With Lenvatinib

Interventions

Pucotenlimab Combined With LenvatinibDRUG

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

Pucotenlimab combined with Lenvatinib as neoadjuvant therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +5 more criteria

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Other (Non U.s.), 0755, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

November 11, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)