Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05926700
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Candonilimab — DRUG
    The patients were treated with Candonilimab + anlotinib, with Cadonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was orally administered for 2 weeks and stopped for a week, with 21 days as a course of treatment.

Study Details

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.

Key Dates

First listed
Jul 3, 2023
Start date
Feb 28, 2024
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention group
    The subject will be treated with Candonilimab + anlotinib every 21 days as a treatment cycle: Candonilimab 10mg/kg, D1 administration; Anlotinib 12mg/ day was taken orally for 2 weeks and stopped for a week. Until the subject has disease progression, intolerable toxicity, and the investigator's decision, the subject withdraws informed consent, death or other reasons specified in the protocol.

Primary Outcome Measure

Progression-Free-Survival （PFS） [ Time Frame: through study completion，an average of 1 year ]

Central Contacts

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