Actively Recruiting
Single Arm, Open Phase II Trial of Chidamide Combined With AK112 for Advanced Bone and Soft Tissue Sarcoma After First-line Treatment
Led by Shanxi Province Cancer Hospital · Updated on 2024-10-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Xidabenzamide with AK112 for patients with advanced bone and soft tissue sarcoma who have already tried at least one prior treatment. This Phase II clinical trial aims to find out how well this combination works in controlling disease progression and improving survival and quality of life. The study also monitors safety and how well patients tolerate the treatment. Participants will receive Chidamide Tablets at a dose of 30 mg twice a week taken orally, with at least three days between doses, and AK112 administered once every three weeks intravenously. The treatment continues under the supervision of a doctor who monitors the participant’s health and adjusts doses if needed. The study includes physical exams and lab tests during the treatment period to evaluate effects and manage any side effects. During the trial, participants will undergo regular tumor assessments every six weeks to measure response to therapy using established evaluation criteria. Researchers will also track overall survival, quality of life, and safety indicators throughout the study. The total participation period includes these ongoing assessments and monitoring until the study ends or the participant stops treatment.
CONDITIONS
Brief 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...
- Patient voluntarily agrees to participate and signs informed consent
- Diagnosed with advanced bone or soft tissue sarcoma confirmed by pathology, with at least one measurable lesion as per RECIST 1.1
- Experienced disease progression or failure after first-line standard treatment
- Aged 18 to 75 years with ECOG performance status of 0 to 1
- Expected survival longer than 3 months
- Adequate organ and bone marrow function without severe dysfunction or immunodeficiency
- Specific blood test values within defined limits, including hemoglobin, neutrophil count, platelet count, bilirubin, liver enzymes, creatinine, and heart function
- Thyroid hormone levels within normal range
- Women of childbearing potential agree to use contraception and test negative for pregnancy before enrollment
- Men agree to use contraception during the 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 (PD-1, PD-L1, CTLA-4)
- Other malignancies within 5 years except certain cured or non-invasive tumors
- Systemic anti-tumor therapy within 28 days before study treatment
- Use of Chinese herbal or traditional medicines with anti-tumor effects within 7 days before treatment
- Planned anti-tumor therapy during study or shortly before enrollment
- Presence of pleural effusion or ascites causing moderate or worse respiratory symptoms
- Unresolved severe toxic reactions from prior treatments
- Symptomatic brain metastases or recent symptom control less than 2 months
- Severe uncontrolled illnesses including poor blood pressure control, significant heart disease, active infections, liver disease, renal failure requiring dialysis, immunodeficiency, uncontrolled diabetes, significant proteinuria, epilepsy requiring treatment
- Major surgery or significant trauma within 28 days before enrollment
- History or signs of bleeding or recent severe 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 preventing quitting
- Participation in other anti-tumor drug trials within 28 days
- Other conditions judged by researchers to risk safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Ongoing until disease progression or discontinuation
Participants receive Chidamide Tablets twice a week orally and AK112 intravenously once every 3 weeks. Physical and laboratory examinations are conducted to evaluate the impact of the treatment.
Visits every 3 weeks for AK112 infusion and regular assessments
Trial Site Locations
Total: 1 location
1
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
X
Xin Wang, Dr
R
Rui Wang, Dr
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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