The primary objective is to evaluate the improvement in Objective Response Rate (ORR) achieved with Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) in combination with Lenvatinib or Axitinib, in patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have failed first-line systemic therapy.
Age at Diagnosis: ≥18 years.
Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma.
Disease progression or intolerance during or following first-line systemic therapy.
ECOG Performance Status: 0-1.
Allergy to any component of macromolecular protein preparations; contraindications or hypersensitivity to any ingredient of Iparomlimab and Tuvonralimab Injection, Lenvatinib, or Axitinib.
Major surgery within 28 days prior to the first dose (excluding diagnostic laparoscopy; local surgery for isolated lesions is acceptable).
Positive Hepatitis B surface antigen (HBsAg) with HBV DNA >1×10³ copies/mL, or positive anti-Hepatitis C virus (HCV) antibody.
Positive anti-HIV antibody or a diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
Single group
Iparomlimab and Tuvonralimab Injection in combination with Lenvatinib or Axitinib
DrugIparomlimab and Tuvonralimab Injection: 5 mg/kg, iv, q3w, for a cumulative maximum treatment duration of 2 years; Lenvatinib: Starting dose of 12 mg, po, qd, q3w; or Axitinib: 5 mg, po, bid, q3w.
Objective response rate
the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.
Progression-Free Survival (PFS)
PFS was defined as the time from first dose of study treatment to the first documented PD per REClST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.
Duration of Response
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death，whichever occurs first.
Overall survival
OS was defined as the time from the first dose of study drug to death due to any cause.
Adverse Events
An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment.
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