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

NCT07389629 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-FXY-071
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Iparomlimab and Tuvonralimab; Clear Cell Renal Cell Carcinoma; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Decline rate of tumor R.E.N.A.L score

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

Secondary Outcomes (1)

• ORR

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

Study Arms (1)

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.

Drug: QL1706 Combined With Lenvatinib

Interventions

QL1706 Combined With Lenvatinib DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, 0755, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Zhiling Zhang, M.D

CONTACT

+862087342318; zhangzhl@sysucc.org.cn

Yulu Peng, M.D

CONTACT

+862087342318; pengyl1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: November 21, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)