Iparomlimab and TuvonralimabPhase 2NCT07389629
Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
A Phase 2 study testing QL1706 Combined With Lenvatinib in people with Iparomlimab and Tuvonralimab and Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Iparomlimab and Tuvonralimab, Clear Cell Renal Cell Carcinoma, Neoadjuvant Therapy
- What is being tested?
- QL1706 Combined 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
- 25 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2025to 31 Dec 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is >= 18 and under 80 years old, with no gender restrictions.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
- Expected survival period >= 3 months.
- Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;
- ECOG score 0 or 1;
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- The patient is willing to undergo kidney preservation surgery;
- Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score >= 10);
- At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.
- Good organ function, screening laboratory test results meet the following criteria: (1) Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment): a. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1500/mm^3); b. Platelet count (PLT) >= 100 × 10^9/L (100000/mm^3); c. Hemoglobin (HB) >= 90 g/L; (2) Liver: a. Serum total bilirubin (TBIL) <= 1.5 × ULN; b. Alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 × ULN; For subjects with liver metastases, AST and ALT are <= 5 × ULN, while serum albumin (ALB) is >= 28g/L. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) are <= 1.5 × ULN;
- The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Who cannot join
- lymph node metastasis;
- The tumor surrounds the renal artery;
- Renal vein cancer thrombus;
- Diffuse tumor growth, with no clear boundary from normal renal parenchyma;
- General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;
- Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes;
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- Patients who have long-term use of immunosuppressants after organ transplantation;
- Patients who are currently using immunosuppressive drugs;
- Patients with clear infection or fever;
- Patients with T-cell lymphoma and myeloma;
- Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months;
- Metastatic renal cell carcinoma.
- Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug;
- Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
- Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.
- Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.
- Known history of mental illness, drug abuse, alcoholism, or drug use.
- Pregnant or lactating women.
- Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
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, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 0755
Zhiling Zhang, M.D, +862087342318, zhangzhl@sysucc.org.cn
Yulu Peng, M.D, +862087342318, pengyl1@sysucc.org.cn
About this study
Official title: The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study
Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score >= 10).
- Being tested
- QL1706 Combined With Lenvatinib
- Keywords
- Iparomlimab and Tuvonralimab, Clear Cell 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.
QL1706 Combined With LenvatinibDrug
Lenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight ≥ 60 kg]) orally once daily, with or without food.
Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapy | Experimental | Lenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight ≥ 60 kg]) orally once daily, with or without food.
Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles. Receives: Drug: QL1706 Combined With Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline rate of tumor R.E.N.A.L score
Measured: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment
Secondary outcomes (1)
ORR
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Measured: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start21 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iparomlimab and TuvonralimabStudies 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
- 25 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
- NCT07389629
- Sponsor's protocol ID
- 2025-FXY-071
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07389629
- Acronym / sponsor ID
- 2025-FXY-071
- Keywords
- Iparomlimab and Tuvonralimab, Clear Cell Renal Cell Carcinoma, Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Feb 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.
Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score >= 10).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapy | Experimental | Drug: QL1706 Combined With LenvatinibLenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight ≥ 60 kg]) orally once daily, with or without food. Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is >= 18 and under 80 years old, with no gender restrictions.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
- Expected survival period >= 3 months.
- Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;
Key exclusion criteria (19 listed)
- lymph node metastasis;
- The tumor surrounds the renal artery;
- Renal vein cancer thrombus;
- Diffuse tumor growth, with no clear boundary from normal renal parenchyma;
- General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;
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 |
|---|---|---|
| QL1706 Combined With LenvatinibLenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight ≥ 60 kg]) orally once daily, with or without food. Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles. | Drug | Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapy |
Primary outcome
Decline rate of tumor R.E.N.A.L score
Time frame: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment
1 secondary outcome
ORR
Time frame: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment
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 5 Feb 2026.
- 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.
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 QL1706 Combined With Lenvatinib in people with Iparomlimab and Tuvonralimab and Clear Cell 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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Zhiling Zhang, M.D (+862087342318, zhangzhl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline rate of tumor R.E.N.A.L score (time frame: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 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 5 Feb 2026.