Actively Recruiting
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-08
27
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Voluntarily signed written informed consent
- Confirmed advanced or unresectable soft tissue sarcoma by pathology including specified types
- Previously treated with at least one chemotherapy regimen (except for acinar and clear cell sarcoma) with disease progression within 6 months
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function including blood counts, kidney, liver, and coagulation within specified limits
- Negative pregnancy test for women of childbearing potential within 3 days before first medication
- Women with childbearing potential must use acceptable contraception during and for 6 months after treatment
- Willingness and ability to comply with study visits, treatment, and tests
You will not qualify if you...
- Participation in other experimental drug or device treatments within 4 weeks before study drug
- Other active malignancies within 3 years except certain cured cancers
- Concurrent enrollment in another clinical study unless observational or follow-up only
- Active autoimmune diseases requiring systemic treatment within 2 years except specified exceptions
- Active inflammatory bowel disease requiring treatment
- Use of systemic corticosteroids over 10 mg prednisone equivalent within 14 days after study drug start except allowed forms
- Prior treatment with immune checkpoint inhibitors or immune cell therapies
- Disease progression or limited response from prior anlotinib treatment
- Known HIV infection or AIDS
- History of allogeneic organ or stem cell transplantation
- Interstitial lung disease
- Necrotic lesions with bleeding risk
- Serious infections within 4 weeks before first dose
- Active pulmonary tuberculosis
- Untreated or unstable hepatitis B or active hepatitis C
- Radiotherapy or anti-tumor treatment within 4 weeks before first dose
- Major surgery within 30 days before first dose or incomplete recovery
- Active brain metastases or related central nervous system conditions unless stable and asymptomatic
- Uncontrolled pleural, pericardial effusion, or ascites
- Uncontrolled serious concurrent diseases or recent serious thromboembolic events
- Unresolved toxicity from prior anti-tumor treatments except hair loss or stable irreversible toxicity
- Live vaccine within 30 days before first dose or planned during study
- Known severe hypersensitivity to monoclonal antibodies or allergy to candonilimab components
- Pregnant or lactating women
- Any condition increasing risk or interfering with study drug safety or evaluation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
Research Team
Y
Ying Dong
CONTACT
R
Rui Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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