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Study on the Safety and Efficacy of Iparomlimab and Tuvonralimab Combined with Lenvatinib as Neoadjuvant Therapy for High-Risk Localized and Locally Advanced Renal Cell Carcinoma

Study on the Safety and Efficacy of Iparomlimab and Tuvonralimab Combined with Lenvatinib as Neoadjuvant Therapy for High-Risk Localized and Locally Advanced Renal Cell Carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108135
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-09-16
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk localized and locally advanced renal cell carcinoma

Interventions

Test group:Iparomlimab and Tuvonralimab

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily signed written informed consent (ICF); 2.18=3 months; 8. Good vital organ function and bone marrow status; 9. Subject is willing and able to comply with scheduled visits, treatment protocol, laboratory tests, and other study requirements.

Exclusion criteria

Exclusion criteria: 1. Poor general condition, anesthesia evaluation cannot tolerate general anesthesia surgery; 2. Severe cardiovascular and cerebrovascular disease, uncontrolled hypertension and diabetes; 3. Patients who have been using immunosuppressants for a long time after organ transplantation or who are using immunosuppressive drugs; 4. Patients with other malignant tumors, or who are being treated for other benign malignancies, or who have a history of other malignancies in the past six months; 5. Received traditional Chinese medicine treatment with anti-tumor or immunomodulatory effects within 14 days before the first use of study drug; or have received systemic treatment (including thymus, interferon, interleukin, etc., except for topical use to control pleural effusion); 6. Active or likely recurrent autoimmune diseases, except vitiligo, alopecia, psoriasis, or eczema that do not require systematic treatment; 7. Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study; 8. Known history of mental illness, drug abuse, alcohol or drug use; 9. Pregnant or breastfeeding women; 10. There are any other factors that may confound the results of the study, interfere with the subject's full participation in the study, or the investigator believes that the subject is not suitable for participation.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall Survival, OS;AE;Pathological complete response rate, pCR;Event-free survival, EFS;

Countries

China

Contacts

Public ContactQinghua Xia

Shandong Provincial Hospital

xiaqh2016@163.com+86 15168889221

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026