Actively Recruiting
A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-18
53
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin.
CONDITIONS
Official Title
A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed soft tissue sarcoma excluding certain subtypes like alveolar/embryonal rhabdomyosarcoma, clear cell sarcoma, and others
- Diagnosed with progressive disease unsuitable for surgery
- No prior systemic therapy for advanced soft tissue sarcoma, and at least 6 months since last neoadjuvant/adjuvant therapy with limited prior adriamycin exposure
- Measurable disease defined and monitored by RECIST v1.1
- Aged 18 years or older and younger than 60 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, amputees can be 0-2
- Expected survival longer than 3 months
- Adequate organ and bone marrow function as defined by specific laboratory values
- Cardiac function within defined normal limits including ECG, LVEF, and biomarkers
- Signed informed consent and willingness to comply with study procedures
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception; men must agree to use contraception during and after treatment
You will not qualify if you...
- Allergy to recombinant humanized anti-PD-1 or anti-CTLA-4 monoclonal antibodies or cadonilimab components
- Cardiac disease class II or higher by NYHA classification
- Received palliative radiotherapy within 2 weeks before treatment start
- Other active malignancy within 5 years except certain cured local cancers
- Concurrent participation in another clinical interventional study
- Active autoimmune disease requiring systemic therapy within 2 years or likely to recur
- Active inflammatory bowel disease requiring management
- Need for systemic corticosteroids or immunosuppressive drugs within 14 days before treatment
- HIV/AIDS diagnosis
- History of organ or stem cell transplantation
- History or presence of interstitial lung disease
- Received live vaccine within 30 days before treatment or planned during study
- Necrotic lesions posing bleeding risk
- Serious infections within 4 weeks before treatment
- Active tuberculosis
- Untreated or unstable hepatitis B or active hepatitis C infection
- Major surgery within 30 days before treatment without full recovery
- Presence of certain brain or meningeal metastases with exceptions
- Unstable pleural, pericardial effusions, or ascites
- Uncontrolled serious co-morbidities or recent arterial thromboembolic events
- Unresolved toxicities from previous cancer therapies
- Pregnant or breastfeeding females
- Any condition posing safety risks or interfering with study 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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
L
li fan, doctor
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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