Actively Recruiting
A Clinical Trial Assessing the Safety and Efficacy of Intravenous CD-801 for the Treatment of Patients With Advanced Hepatocellular Carcinoma
Led by Shanghai Changzheng Hospital · Updated on 2025-04-24
37
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the safety, tolerability, and effectiveness of intravenous CD-801 in adults with advanced hepatocellular carcinoma (HCC), a common form of liver cancer. The study explores a new drug designed to target liver cancer cells and help restore a key protein, HNF4b1, which is important for liver cell function and may influence cancer growth. The trial is open-label and single-arm, aiming to improve treatment options for patients with advanced HCC who have limited current therapies. The study is conducted in two phases: dose escalation and dose expansion. During the dose escalation phase, participants receive increasing doses of CD-801 (25, 50, or 100 bcg) intravenously to assess safety and determine the best dose. The dosing schedule includes a second dose about 14 days after the first, followed by doses every 28 days, adjusted based on patient tolerance and response. In the dose expansion phase, about 10 participants will receive the selected safe dose under the same schedule, with treatment continuing until disease progression, toxicity, withdrawal, or other criteria. Patients who have undergone prior cycles of the related therapy may continue or adjust their dose combined with other cancer treatments. Participants will receive CD-801 through a peripheral vein and undergo regular assessments including tumor measurements using mRECIST criteria to evaluate response. Safety and tolerability are closely monitored throughout the study, with follow-up assessments 14 days after the last dose. The primary outcomes include safety evaluation and the objective response rate to treatment. Secondary measures include duration of response, progression-free survival, overall survival, and other tumor response rates. The total participation time varies depending on individual response and study progression, with assessments continuing up to 24 months or longer for survival monitoring.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older
- Confirmed diagnosis of hepatocellular carcinoma (HCC) based on American Association for the Study of Liver Diseases criteria
- Unresectable hepatocellular carcinoma
- Not eligible for locoregional or systemic therapies, or had disease progression, or would not benefit after at least one conventional therapy
- At least one measurable target lesion according to mRECIST
- Life expectancy of 12 weeks or more
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Males with fertility and females of childbearing potential willing to use effective contraception during the study and for 6 months after treatment
- Negative pregnancy test within 7 days before first dose for females of childbearing potential
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Albumin less than 25 g/L or total bilirubin greater than 5 times the upper limit of normal
- Aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) greater than 10 times the upper limit of normal
- Creatinine greater than 1.5 times the upper limit of normal or creatinine clearance less than 40 mL/min
- Absolute neutrophil count less than 1.0 x10^9/L, platelets less than 30 x10^9/L, or hemoglobin less than 8.5 g/dL
- International Normalized Ratio (INR) greater than 2.3
- History of liver transplantation
- Poorly controlled hypertension, diabetes, serious heart or lung diseases, or serious dysfunction
- Extrahepatic metastasis without prior first-line systemic therapies or currently receiving effective systemic therapy
- Recent anticancer treatment within 2 to 4 weeks before first dose, except treatments after which disease progressed
- Ongoing toxicities grade 2 or higher from prior treatments, except for hair loss or tolerable events
- Recent complications of liver cirrhosis or HCC such as gastrointestinal bleeding, hepatic encephalopathy, or refractory ascites within 2 weeks before first dose
- Uncontrolled active infections
- History of other malignancies within 5 years except low-risk cancers
- Hepatitis B or C viral loads above specified limits
- Positive for Human Immunodeficiency Virus (HIV)
- Allergy to MRI contrast agents
- Pregnant or lactating women or those who may become pregnant
- Participation in other investigational drug trials within 4 weeks prior to study
- Any condition that would prevent safe participation as judged by the investigator
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 visit (in-person)
Duration - Up to 2 years
Participants receive intravenous CD-801 for advanced hepatocellular carcinoma. The dosing schedule includes a second dose approximately 14 days after the initial treatment, followed by subsequent treatments approximately every 28 days, with adjustments based on tolerance and response.
Repeated visits every 14 to 28 days for treatment administration
Duration - Up to 2 years after treatment completion
Participants are monitored for safety and efficacy outcomes after completing treatment with CD-801, including assessments of tumor response and overall survival, for up to 2 years.
Periodic visits for outcome assessments
Trial Site Locations
Total: 1 location
1
Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
C
CHUAN YIN, M.D.
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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