Iparomlimab and Tuvonralimab plus lenvatinib before kidney-sparing surgery for clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional approach gives a combination of two monoclonal antibodies (Iparomlimab and Tuvonralimab as QL1706) together with the oral kinase inhibitor lenvatinib before planned partial nephrectomy in patients with localized clear cell renal cell carcinoma. The target population is adults with T1N0M0 or T2N0M0 tumors that are technically difficult for nephron-sparing surgery (R.E.N.A.L. score ≥10) but who wish to preserve the kidney. The goal is to shrink or modify tumors to permit safer and more successful partial nephrectomy while monitoring safety and organ function. Procedures will include baseline biopsy-confirmed pathology, imaging measurements using mRECIST criteria, neoadjuvant combination therapy, and planned surgery if criteria are met.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Zhiling Zhang, M.D
• Email: zhangzhl@sysucc.org.cn
• Phone: +862087342318

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• MRD-guided postoperative monitoring and adaptive treatment for resectable NSCLC

  This study tests a personalized follow-up and treatment plan using ctDNA MRD testing and pathology to guide adjuvant therapy after surgery for stage IB-IIIA NSCLC treated with neoadjuvant immunotherapy.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07894458

• MRG003 added to ongoing treatment after progression in EGFR-positive advanced thyroid cancer

  In this study, researchers test whether adding MRG003 to a patient’s current thyroid cancer treatment can shrink tumors for those whose cancer initially responded but later progressed.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07874321

• Perioperative therapy with Retlirafusp alfa, Famitinib, and HAIC-GEMOX for locally advanced intrahepatic cholangiocarcinoma

  This trial tests whether a perioperative treatment combo (Retlirafusp alfa, famitinib, and HAIC-GEMOX) can help shrink or control locally advanced intrahepatic cholangiocarcinoma before surgery and support additional therapy afterward in adults.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07847710

• Cryoablation with liver-directed immunotherapy and targeted therapy for melanoma liver metastases

  This trial tests a combination therapy including cryoablation, hepatic artery delivery of QL1706, intravenous dacarbazine, and oral lenvatinib to treat liver metastases from malignant melanoma in adults.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07847359

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.