Urologic NeoplasmsPhase 2NCT07741617
A Prospective, Single-Arm, Multicenter Clinical Study of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma
A Phase 2 study testing Iparomlimab and Tuvonralimab in combination with Lenvatinib in people with Urologic Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Study Design Prospective, single-arm, multicenter clinical study. Study Drugs Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib. Adjuvant phase: QL1706 monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- Iparomlimab and Tuvonralimab in combination with Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 15 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and agree to comply with the study requirements and assessment schedule, and voluntarily provide written informed consent (ICF) prior to any trial-related procedures.
- Age ≥ 18 years and ≤ 75 years, male or female.
- Histologically or cytologically confirmed localized and locally advanced clear cell renal cell carcinoma.
- Locally advanced renal cell carcinoma (stage III per AJCC): cT3a G3-4 cN0 M0; cT3b-T4 Gany cN0 M0; cTany cN1 Gany cM0; or high-risk localized renal cell carcinoma: cT1b G4 or with sarcomatoid features cN0 cM0; cT2 G3-4 cN0 cM0.
- No prior treatment with any immune checkpoint inhibitor.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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- Life expectancy ≥ 3 months.
- At least one measurable lesion according to RECIST v1.1.
- Planned to receive neoadjuvant therapy and surgical resection.
- Adequate major organ function within 7 days prior to treatment, meeting the following criteria: A. Hematology: absolute neutrophil count ≥ 1.5 × 10⁹/L; hemoglobin ≥ 80 g/L; platelet count ≥ 90 × 10⁹/L. B. Blood biochemistry: total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (for subjects with liver metastases, ALT or AST ≤ 5 × ULN is permitted); serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. C. Left ventricular ejection fraction ≥ 50%. D. Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤ 1.5 × ULN. E. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or free T3) and free T4 within the normal range are also eligible. F. Cardiac enzymes and troponin within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed).
- Female subjects of childbearing potential must agree to use effective contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study and for 6 months after study completion; serum pregnancy test must be negative within 72 hours prior to the first dose, and they must not be breastfeeding. Male subjects must agree to use effective contraception during the study and for 6 months after study completion.
Who cannot join
- Presence of symptomatic or untreated known brain metastases or other central nervous system (CNS) metastases. CNS metastases that have been completely resected and/or irradiated with documented stability or improvement are not exclusionary, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, with no evidence of cerebral edema and no requirement for glucocorticoids or anticonvulsants
- Patients with advanced or metastatic renal cell carcinoma, or non-clear cell renal cell carcinoma
- Known hypersensitivity to the investigational product or any of its excipients; or previous allergy to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Prior discontinuation of immunotherapy due to severe and/or life-threatening immune-related adverse events
- Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per NCI-CTCAE v5.0 at enrollment (except for alopecia or other toxicities deemed by the investigator to be tolerable and not clinically significant)
- Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients on hormone replacement therapy may be considered for inclusion); patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention in adulthood may be considered, but those requiring bronchodilators for medical intervention are excluded
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- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Presence of poorly controlled cardiac symptoms or diseases, including but not limited to: heart failure ≥ NYHA class II, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention
- Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection or need for oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug (prophylactic antibiotics are allowed).
- Active pulmonary tuberculosis infection identified by history or CT, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate treatment.
- Positive HBV DNA test; hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of quantification of the assay).
- Diagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with low risk of metastasis or death, such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for enrollment.
- Known hereditary or acquired bleeding or thrombotic tendency (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.), or currently receiving thrombolytic or anticoagulant therapy.
- Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as daily hemoptysis ≥ 2.5 mL, lower gastrointestinal bleeding, esophageal-gastric varices with bleeding risk, bleeding gastric ulcer, or vasculitis, etc.
- Arterial/venous thrombotic events occurring within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
- Pregnant or breastfeeding female patients.
- According to the investigator's judgment, any other factors that may compel premature termination of the study, such as other serious concomitant diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect subject safety or compliance.
- Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up of an interventional study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Hongqian Guo, Chief Physician, 025-68182222, dr.ghq@163.com
Hongqian Guo, Chief Physician
About this study
Official title: A Prospective, Single-Arm, Multicenter Clinical Study of Epalolitoworelimab (a PD-1/CTLA-4 Combination Antibody) Combined With Lenvatinib in the Perioperative Treatment of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma
Study Design Prospective, single-arm, multicenter clinical study.
Study Drugs
Read more
Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib.
Adjuvant phase: QL1706 monotherapy.
Target Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection.
Treatment Flow
Screening (28 days): Informed consent obtained, baseline assessments completed.
Neoadjuvant phase (4 cycles, 21 days/cycle):
QL1706 5 mg/kg IV, Q3W; plus oral lenvatinib 12 mg QD.
Efficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination).
Adjuvant phase (13-17 cycles, 21 days/cycle):
Eligible patients continue QL1706 5 mg/kg IV, Q3W.
Imaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total.
Follow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days.
Endpoints
Primary: Objective response rate (ORR) per RECIST 1.1.
Secondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-/24-month DFS rates, median overall survival (mOS), and safety.
Sample Size Planned enrollment: 54 subjects.
Read the detailed description
This is a prospective, single-arm, multicenter clinical study designed to evaluate the efficacy and safety of QL1706 (an anti-PD-1/CTLA-4 combination antibody, also known as *Aipaluo Tuoworilimab*) combined with lenvatinib as neoadjuvant therapy for high-risk localized and locally advanced clear cell renal cell carcinoma (ccRCC), followed by QL1706 monotherapy as postoperative adjuvant therapy.
---
Study Population
Patients with histologically or cytologically confirmed locally advanced or high-risk localized clear cell renal cell carcinoma who are candidates for neoadjuvant therapy and surgical resection, defined by the following staging criteria (AJCC):
- Locally advanced (Stage III ccRCC):
- cT3a G3-4 cN0 M0;
- cT3b-T4 G<sub>any</sub> cN0 M0;
- cT<sub>any</sub> cN1 G<sub>any</sub> M0;
- High-risk localized ccRCC:
- cT1b G4 or with sarcomatoid features, cN0 cM0;
- cT2 G3-4, cN0 M0.
Study Phases The study consists of four phases: Screening, Neoadjuvant Treatment, Postoperative Adjuvant Treatment, and Follow-up.
- Screening Period (28 days): After signing informed consent, eligible subjects undergo screening evaluations and assessments. Those who meet all inclusion/exclusion criteria proceed to treatment.
Neoadjuvant Treatment Period (21-day cycles)
- From Cycle 1, on Day 1 of each cycle, subjects receive QL1706 5 mg/kg intravenously, Q3W, for 4 cycles. If the infusion is interrupted, the total interruption time is permitted to be ≤8 hours (at room temperature).
- Concurrently, from Cycle 1, subjects receive oral lenvatinib 12 mg once daily (QD) for 4 cycles (21 days/cycle).
- Tumor response is evaluated every 2 cycles using RECIST 1.1.
- Subjects proceed to surgical resection after completion of 4 cycles, unless a termination event occurs (clinical progression, radiographic progression confirmed by the investigator per RECIST 1.1, unacceptable toxicity, withdrawal of informed consent, or meeting criteria for treatment discontinuation).
Adjuvant Treatment Period (21-day cycles)
- Based on postoperative pathology results, subjects who are eligible for adjuvant immunotherapy (as assessed by the investigator and with patient consent) will receive adjuvant therapy.
- QL1706 5 mg/kg is administered intravenously on Day 1 of each 21-day cycle for 13-17 cycles. Infusion interruption is allowed for a total of ≤8 hours (at room temperature).
- Imaging assessments are performed every 3 months (±7 days) after treatment initiation until recurrence/metastasis, initiation of new anti-cancer therapy, withdrawal of consent, or death, or until a maximum of 21 cycles of treatment (whichever occurs first). Additional imaging may be performed at any time if clinically indicated.
At the end of treatment, subjects undergo safety assessments and imaging evaluations, followed by a safety follow-up visit up to 90 days after the last dose of QL1706 or 30 days after the last dose of other study drugs (whichever is longer). After the safety follow-up, survival follow-up is performed every 90 days (±7 days) to collect and record survival status and subsequent anti-cancer treatments.
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Study Endpoints
- Primary endpoint: Objective response rate (ORR) assessed by the investigator per RECIST 1.1.
- Secondary endpoints: Pathological complete response rate (pCR rate), median disease-free survival (mDFS), 12-month and 24-month DFS rates, median overall survival (mOS), and safety profile.
Sample Size The study plans to enroll 54 subjects.
- Conditions
- Urologic Neoplasms
- Being tested
- Iparomlimab and Tuvonralimab in combination with Lenvatinib
- Keywords
- high risk, locally advanced, ccECC
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab in combination with LenvatinibDrug
Neoadjuvant phase (4 cycles, 21 days/cycle):
From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature.
Concurrent oral lenvatinib 12 mg once daily for 4 cycles.
Tumor response assessed every 2 cycles.
After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria.
Adjuvant phase (13-17 cycles, 21 days/cycle):
Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment.
QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles.
No lenvatinib in this phase.
Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested.
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT GROUP（Iparomlimab and Tuvonralimab in combination with Lenvatinib ） | Experimental | Summary of Neoadjuvant and Adjuvant Treatment Periods
Neoadjuvant phase (4 cycles, 21 days/cycle):
From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature.
Concurrent oral lenvatinib 12 mg once daily for 4 cycles.
Tumor response assessed every 2 cycles.
After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria.
Adjuvant phase (13-17 cycles, 21 days/cycle):
Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment.
QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles.
No lenvatinib in this phase.
Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested. Receives: Drug: Iparomlimab and Tuvonralimab in combination with Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
During the neoadjuvant treatment phase, the objective response rate (ORR) is defined as the percentage of subjects who achieve complete response (CR) or partial response (PR).
Measured: every 6 weeks to 2 years assessed by the investigator per RECIST v1.1.
Secondary outcomes (2)
Pathological Complete Response Rate(pCR)
After neoadjuvant treatment, subjects undergo surgical resection, and the percentage of subjects who achieve pathological complete response (pCR) on pathological evaluation is calculated.
Measured: within 1-4 weeks postoperatively,Pathological assessment
Disease-Free Survival(DFS)
Time from surgery to disease recurrence or metastasis.
Measured: within 2 years after surgery,imaging follow-up evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic NeoplasmsStudies of the same condition, open and under way.
- 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
- Model description
- Summary of Neoadjuvant and Adjuvant Treatment Periods Neoadjuvant phase (4 cycles, 21 days/cycle): From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature. Concurrent oral lenvatinib 12 mg once daily for 4 cycles. Tumor response assessed every 2 cycles. After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria. Adjuvant phase (13-17 cycles, 21 days/cycle): Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment. QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles. No lenvatinib in this phase. Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital, Changzhou No.2 People's Hospital
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741617
- Sponsor's protocol ID
- QL-RCC-QIBA-3010
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 3 Aug 2026
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Multicenter Clinical Study of Epalolitoworelimab (a PD-1/CTLA-4 Combination Antibody) Combined With Lenvatinib in the Perioperative Treatment of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07741617
- Acronym / sponsor ID
- QL-RCC-QIBA-3010
- Conditions
- Urologic Neoplasms
- Keywords
- high risk, locally advanced, ccECC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Wuxi No. 2 People's Hospital, Changzhou No.2 People's Hospital
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 3 Aug 2026 (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.
Study Design Prospective, single-arm, multicenter clinical study.
Study Drugs
Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib.
Adjuvant phase: QL1706 monotherapy.
Target Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection.
Treatment Flow
Screening (28 days): Informed consent obtained, baseline assessments completed.
Neoadjuvant phase (4 cycles, 21 days/cycle):
QL1706 5 mg/kg IV, Q3W; plus oral lenvatinib 12 mg QD.
Efficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination).
Adjuvant phase (13-17 cycles, 21 days/cycle):
Eligible patients continue QL1706 5 mg/kg IV, Q3W.
Imaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total.
Follow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days.
Endpoints
Primary: Objective response rate (ORR) per RECIST 1.1.
Secondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-/24-month DFS rates, median overall survival (mOS), and safety.
Sample Size Planned enrollment: 54 subjects.
Detailed description
This is a prospective, single-arm, multicenter clinical study designed to evaluate the efficacy and safety of QL1706 (an anti-PD-1/CTLA-4 combination antibody, also known as *Aipaluo Tuoworilimab*) combined with lenvatinib as neoadjuvant therapy for high-risk localized and locally advanced clear cell renal cell carcinoma (ccRCC), followed by QL1706 monotherapy as postoperative adjuvant therapy.
---
Study Population
Patients with histologically or cytologically confirmed locally advanced or high-risk localized clear cell renal cell carcinoma who are candidates for neoadjuvant therapy and surgical resection, defined by the following staging criteria (AJCC):
- Locally advanced (Stage III ccRCC):
- cT3a G3-4 cN0 M0;
- cT3b-T4 G<sub>any</sub> cN0 M0;
- cT<sub>any</sub> cN1 G<sub>any</sub> M0;
- High-risk localized ccRCC:
- cT1b G4 or with sarcomatoid features, cN0 cM0;
- cT2 G3-4, cN0 M0.
Study Phases The study consists of four phases: Screening, Neoadjuvant Treatment, Postoperative Adjuvant Treatment, and Follow-up.
- Screening Period (28 days): After signing informed consent, eligible subjects undergo screening evaluations and assessments. Those who meet all inclusion/exclusion criteria proceed to treatment.
Neoadjuvant Treatment Period (21-day cycles)
- From Cycle 1, on Day 1 of each cycle, subjects receive QL1706 5 mg/kg intravenously, Q3W, for 4 cycles. If the infusion is interrupted, the total interruption time is permitted to be ≤8 hours (at room temperature).
- Concurrently, from Cycle 1, subjects receive oral lenvatinib 12 mg once daily (QD) for 4 cycles (21 days/cycle).
- Tumor response is evaluated every 2 cycles using RECIST 1.1.
- Subjects proceed to surgical resection after completion of 4 cycles, unless a termination event occurs (clinical progression, radiographic progression confirmed by the investigator per RECIST 1.1, unacceptable toxicity, withdrawal of informed consent, or meeting criteria for treatment discontinuation).
Adjuvant Treatment Period (21-day cycles)
- Based on postoperative pathology results, subjects who are eligible for adjuvant immunotherapy (as assessed by the investigator and with patient consent) will receive adjuvant therapy.
- QL1706 5 mg/kg is administered intravenously on Day 1 of each 21-day cycle for 13-17 cycles. Infusion interruption is allowed for a total of ≤8 hours (at room temperature).
- Imaging assessments are performed every 3 months (±7 days) after treatment initiation until recurrence/metastasis, initiation of new anti-cancer therapy, withdrawal of consent, or death, or until a maximum of 21 cycles of treatment (whichever occurs first). Additional imaging may be performed at any time if clinically indicated.
At the end of treatment, subjects undergo safety assessments and imaging evaluations, followed by a safety follow-up visit up to 90 days after the last dose of QL1706 or 30 days after the last dose of other study drugs (whichever is longer). After the safety follow-up, survival follow-up is performed every 90 days (±7 days) to collect and record survival status and subsequent anti-cancer treatments.
---
Study Endpoints
- Primary endpoint: Objective response rate (ORR) assessed by the investigator per RECIST 1.1.
- Secondary endpoints: Pathological complete response rate (pCR rate), median disease-free survival (mDFS), 12-month and 24-month DFS rates, median overall survival (mOS), and safety profile.
Sample Size The study plans to enroll 54 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Summary of Neoadjuvant and Adjuvant Treatment Periods Neoadjuvant phase (4 cycles, 21 days/cycle): From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature. Concurrent oral lenvatinib 12 mg once daily for 4 cycles. Tumor response assessed every 2 cycles. After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria. Adjuvant phase (13-17 cycles, 21 days/cycle): Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment. QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles. No lenvatinib in this phase. Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested.
| Arm | Type | Receives |
|---|---|---|
| TREATMENT GROUP（Iparomlimab and Tuvonralimab in combination with Lenvatinib ） | Experimental | Drug: Iparomlimab and Tuvonralimab in combination with LenvatinibSummary of Neoadjuvant and Adjuvant Treatment Periods Neoadjuvant phase (4 cycles, 21 days/cycle): From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature. Concurrent oral lenvatinib 12 mg once daily for 4 cycles. Tumor response assessed every 2 cycles. After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria. Adjuvant phase (13-17 cycles, 21 days/cycle): Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment. QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles. No lenvatinib in this phase. Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and agree to comply with the study requirements and assessment schedule, and voluntarily provide written informed consent (ICF) prior to any trial-related procedures.
- Age ≥ 18 years and ≤ 75 years, male or female.
- Histologically or cytologically confirmed localized and locally advanced clear cell renal cell carcinoma.
- Locally advanced renal cell carcinoma (stage III per AJCC): cT3a G3-4 cN0 M0; cT3b-T4 Gany cN0 M0; cTany cN1 Gany cM0; or high-risk localized renal cell carcinoma: cT1b G4 or with sarcomatoid features cN0 cM0; cT2 G3-4 cN0 cM0.
- No prior treatment with any immune checkpoint inhibitor.
Key exclusion criteria (18 listed)
- Presence of symptomatic or untreated known brain metastases or other central nervous system (CNS) metastases. CNS metastases that have been completely resected and/or irradiated with documented stability or improvement are not exclusionary, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, with no evidence of cerebral edema and no requirement for glucocorticoids or anticonvulsants
- Patients with advanced or metastatic renal cell carcinoma, or non-clear cell renal cell carcinoma
- Known hypersensitivity to the investigational product or any of its excipients; or previous allergy to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Prior discontinuation of immunotherapy due to severe and/or life-threatening immune-related adverse events
- Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per NCI-CTCAE v5.0 at enrollment (except for alopecia or other toxicities deemed by the investigator to be tolerable and not clinically significant)
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab in combination with LenvatinibNeoadjuvant phase (4 cycles, 21 days/cycle): From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature. Concurrent oral lenvatinib 12 mg once daily for 4 cycles. Tumor response assessed every 2 cycles. After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria. Adjuvant phase (13-17 cycles, 21 days/cycle): Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment. QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles. No lenvatinib in this phase. Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested. | Drug | TREATMENT GROUP（Iparomlimab and Tuvonralimab in combination with Lenvatinib ） |
Primary outcome
Objective Response Rate(ORR)
Time frame: every 6 weeks to 2 years assessed by the investigator per RECIST v1.1.
During the neoadjuvant treatment phase, the objective response rate (ORR) is defined as the percentage of subjects who achieve complete response (CR) or partial response (PR).
2 secondary outcomes
Pathological Complete Response Rate(pCR)
Time frame: within 1-4 weeks postoperatively,Pathological assessment
Disease-Free Survival(DFS)
Time frame: within 2 years after surgery,imaging follow-up evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
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.
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 Iparomlimab and Tuvonralimab in combination with Lenvatinib in people with Urologic Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 11 inclusion and 18 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: opening soon, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongqian Guo, Chief Physician (025-83106666, dr.ghq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: every 6 weeks to 2 years assessed by the investigator per RECIST v1.1.). 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 3 Aug 2026.