OncoMatch/Clinical Trials/NCT05926700
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment
Is NCT05926700 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Candonilimab for soft tissue sarcoma.
Treatment: Candonilimab — Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months.
Cannot have received: immune checkpoint inhibitor
He has previously received immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.), immune cell therapy and other treatments targeting tumor immune mechanism.
Cannot have received: anlotinib (anlotinib)
Exception: The best swelling evaluation result of patients who had received previous treatment with anlotinib was PD, or SD ≤ 12 weeks.
The best swelling evaluation result of patients who had received previous treatment with anlotinib was PD, or SD ≤ 12 weeks.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/l (1500/mm3); Platelet count ≥ 100 × 10^9/l (100000/mm3); Hemoglobin ≥ 90 g/l
Kidney function
Creatinine clearance (CrCl) ≥ 50 ml/min (Cockcroft Gault formula); Urine protein < 2+ or 24-hour urine protein quantification <1.0 g
Liver function
Total serum bilirubin (TBIL) ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; for subjects with liver metastasis, TBIL ≤ 3 × ULN; ALT and AST ≤ 5 × ULN
The main organs function well: Hematology (no blood components and cell growth factors were used to support treatment within 7 days before starting the study treatment): i. The absolute value of neutrophils ANC ≥ 1.5 × 109/l (1500/mm3). Ii Platelet count ≥ 100 × 109/l (100000/mm3). III. hemoglobin ≥ 90 g/l. Kidney: i. Creatinine clearance * (CrCl) calculated value ≥ 50 ml/min. ... Ii Urine protein < 2+ or 24-hour (H) urine protein quantification <1.0 G. Liver: i. Total serum bilirubin (TBIL) ≤ 1.5 × ULN. II. AST and alt ≤ 2.5 × ULN. III. for subjects with liver metastasis, serum total bilirubin (TBIL) ≤ 3 × ULN; ALT and AST ≤ 5 × ULN; Coagulation function: i. INR and APTT ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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