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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.

Phase 2RecruitingSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNCT05926700Data as of May 2026

Treatment: CandonilimabObjective 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

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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