Actively Recruiting
Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
Led by Shanxi Province Cancer Hospital · Updated on 2024-10-15
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the efficacy and safety of Xidabenzamide combined with AK112 for advanced bone and soft tissue sarcoma of second-line and above.
CONDITIONS
Official Title
Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily consent to participate in the study
- Diagnosed with advanced bone or soft tissue sarcoma confirmed by pathology with at least one measurable lesion according to RECIST 1.1
- Have sarcoma types excluding malignant mesothelioma, acinar soft tissue sarcoma, gastrointestinal stromal tumor, and extra bone mucinous chondrosarcoma
- Experienced disease progression or failure after first-line standard treatment
- Aged 18 to 75 years with ECOG performance status of 0 or 1
- Expected survival longer than 3 months
- Adequate organ and bone marrow function without severe dysfunction or immunodeficiency
- Meet blood test criteria including hemoglobin ≥90g/L, ANC ≥1.5×10⁹/L, platelets ≥80×10⁹/L
- Biochemical tests within specified limits for bilirubin, liver enzymes, and kidney function
- Left ventricular ejection fraction ≥50%
- Thyroid hormone levels within normal range ±10%
- Women of childbearing potential must have negative pregnancy test and agree to use contraception during study and for 6 months after
- Men must agree to use contraception during study and for 6 months after
You will not qualify if you...
- Prior use of sildenafil or other histone deacetylase inhibitors
- Previous treatment with immune checkpoint inhibitors such as PD-1, PD-L1, CTLA-4
- Other malignant tumors within past 5 years except certain cured cancers
- Systemic anti-tumor therapy within 28 days before study treatment
- Use of Chinese herbal medicines with anti-tumor effects within 7 days before treatment
- Planned systemic anti-tumor therapy or recent radiation therapy within specified timeframes
- Presence of pleural effusion or ascites causing respiratory distress grade 2 or higher
- Unresolved toxic reactions above grade 1 except hair loss
- Symptomatic brain metastases or symptom control less than 2 months
- Severe or uncontrolled illnesses including uncontrolled blood pressure, significant heart conditions, severe infections, liver or kidney failure, immunodeficiency, poorly controlled diabetes, significant proteinuria, epilepsy needing treatment
- Major surgery, open biopsy, or significant injury within 28 days before enrollment
- History or signs of bleeding problems or recent serious bleeding events
- Recent arterial or venous thrombotic events within 6 months
- Active ulcers, intestinal perforation, or obstruction
- History of psychotropic drug abuse or mental disorders
- Participation in other anti-tumor drug trials within 28 days
- Any other serious diseases judged by researchers to endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
X
Xin Wang, Dr
CONTACT
R
Rui Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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