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RecruitingNCT07389629Updated Feb 5, 2026

Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

A Phase 2 interventional study of QL1706 Combined With Lenvatinib in Iparomlimab and Tuvonralimab, Clear Cell Renal Cell Carcinoma and Neoadjuvant Therapy, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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 kidney (R.E.N.A.L. score >= 10).

02

Conditions studied

  • Iparomlimab and Tuvonralimab
  • Clear Cell Renal Cell Carcinoma
  • Neoadjuvant Therapy

Keywords

  • Iparomlimab and Tuvonralimab
  • Clear Cell Renal Cell Carcinoma
  • Neoadjuvant therapy
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's planned enrollment of 25 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Voluntarily sign a written informed consent form (ICF).
  2. Age at the time of enrollment is >= 18 and under 80 years old, with no gender restrictions.
  3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
  4. Expected survival period >= 3 months.
  5. Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;
  6. ECOG score 0 or 1;
  7. The patient is willing to undergo kidney preservation surgery;
  8. 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);
  9. At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.
  10. 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;
  11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.

Exclusion criteria

Exclusion Criteria:

  1. lymph node metastasis;
  2. The tumor surrounds the renal artery;
  3. Renal vein cancer thrombus;
  4. Diffuse tumor growth, with no clear boundary from normal renal parenchyma;
  5. General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;
  6. Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes;
  7. Patients who have long-term use of immunosuppressants after organ transplantation;
  8. Patients who are currently using immunosuppressive drugs;
  9. Patients with clear infection or fever;
  10. Patients with T-cell lymphoma and myeloma;
  11. 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;
  12. Metastatic renal cell carcinoma.
  13. Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug;
  14. Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
  15. 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.
  16. Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.
  17. Known history of mental illness, drug abuse, alcoholism, or drug use.
  18. Pregnant or lactating women.
  19. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapy

    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.

    Drug: QL1706 Combined With Lenvatinib

Interventions

  • DrugQL1706 Combined With Lenvatinib

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. ORR

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

    Time frame: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07389629
Lead sponsor
Sun Yat-sen University
Responsible party
ZHOU FANGJIAN (Professor, Sun Yat-sen University) — Principal investigator
First posted
Feb 5, 2026
Start date
Nov 21, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Feb 5, 2026

Study contacts

Zhiling Zhang, M.D
Contact
zhangzhl@sysucc.org.cn
+862087342318
Yulu Peng, M.D
Contact
pengyl1@sysucc.org.cn
+862087342318

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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