QL1706 With Lenvatinib Before Surgery for Clear Cell Kidney Cancer
Tests QL1706 plus lenvatinib before kidney-sparing surgery in adults with kidney cancer.
Key facts
- Who runs it
- Sun Yat-sen University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 25 people, planned
- Started
- 21 Nov 2025
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional
- Treatments tested
- QL1706 Combined With Lenvatinib
- Record updated
- 5 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a localized clear cell kidney cancer who could have kidney-sparing surgery, but where the surgery is very difficult. They get QL1706 with lenvatinib before surgery.
- Age
- 18 to under 80 years
- Sex
- All sexes can join.
- Disease stage
- Kidney cancer confirmed by biopsy as clear cell type, stage T1N0M0 or T2N0M0, with a R.E.N.A.L. score of 10 or more. At least one measurable tumor lesion.
- Earlier treatment
- No Chinese herbal medicine or immune-modulating anti-tumor drugs within 14 days before the first study drug. No other systemic treatment such as thymosin, interferon or interleukin. No immunosuppressive drugs now.
Main reasons for not taking part
- Cancer in the lymph nodes or spread to other organs (metastatic kidney cancer)
- Tumor surrounding the renal artery, a cancer clot in the renal vein, or tumor with no clear edge
- Cannot tolerate general anesthesia, or serious heart or brain blood vessel disease, or uncontrolled high blood pressure or diabetes
- Active autoimmune disease (some mild conditions are allowed), or long-term immunosuppressants after an organ transplant
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
- 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 take part
- Patients who have long-term use of immunosuppressants after organ transplantation
- Patients who are currently using immunosuppressive drugs
- Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug
- Renal vein cancer thrombus
- General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery
- Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes
- Patients with clear infection or fever
- 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
- 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
- Known history of mental illness, drug abuse, alcoholism, or drug use
- 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
- lymph node metastasis
- The tumor surrounds the renal artery
- Diffuse tumor growth, with no clear boundary from normal renal parenchyma
- Patients with T-cell lymphoma and myeloma
- Metastatic renal cell carcinoma
- Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion)
- Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Zhiling Zhang, M.DTaking people
About the trial
What the trial wants to find out
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).
The group in the trial
- Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapyTreatment being tested
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.
Treatment: QL1706 Combined With Lenvatinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- QL1706 With Lenvatinib Before Surgery for Clear Cell Kidney CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07389629, who can take part
- Record updated
- 5 February 2026