Renal Cell CarcinomaPhase 2NCT06129955
Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma
A Phase 2 study testing Pucotenlimab Combined With Lenvatinib in people with Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Pucotenlimab Combined With Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), 0755
Yulu Peng, MD, +862087342318, pengyl1@sysucc.org.cn
About this study
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
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).
Read the 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).
- Conditions
- Renal Cell Carcinoma
- Being tested
- Pucotenlimab Combined With Lenvatinib
- Keywords
- Pucotenlimab, Lenvatinib, Non-clear renal cell carcinoma, Neoadjuvant therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pucotenlimab Combined With LenvatinibDrug
Patients treated by Pucotenlimab combined with Lenvatinib for 3 months before surgery
| Study group | Role | What they receive |
|---|---|---|
| Pucotenlimab combined with Lenvatinib as neoadjuvant therapy | Experimental | Pucotenlimab combined with Lenvatinib as neoadjuvant therapy Receives: Drug: Pucotenlimab Combined With Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Measured: At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Nov 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129955
- Sponsor's protocol ID
- 2023-FXY-181
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06129955
- Acronym / sponsor ID
- 2023-FXY-181
- Conditions
- Renal Cell Carcinoma
- Keywords
- Pucotenlimab, Lenvatinib, Non-clear renal cell carcinoma, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pucotenlimab combined with Lenvatinib as neoadjuvant therapy | Experimental | Drug: Pucotenlimab Combined With LenvatinibPucotenlimab combined with Lenvatinib as neoadjuvant therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pucotenlimab Combined With LenvatinibPatients treated by Pucotenlimab combined with Lenvatinib for 3 months before surgery | Drug | Pucotenlimab combined with Lenvatinib as neoadjuvant therapy |
Primary outcome
ORR
Time frame: At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pucotenlimab Combined With Lenvatinib in people with Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.