The Safety and Efficacy of CD-801 in Patients With Advanced Intrahepatic Cholangiocarcinoma
- Conditions
- Intrahepatic Cholangiocarcinoma
- Registration Number
- NCT06572189
- Lead Sponsor
- Shanghai Changzheng Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Males or females, aged 18 years or older.<br><br> - Histologically or cytologically confirmed intrahepatic cholangiocarcinoma patients.<br><br> - Patients with intrahepatic cholangiocarcinoma not suitable for surgical resection,<br> liver transplantation, or ablation therapy, or those with post-surgical recurrence<br> and/or metastasis.<br><br> - Patients not suitable for local or systemic treatment, or those who have progressed<br> after at least one chemotherapy regimen containing<br> gemcitabine/fluoropyrimidine/platinum, etc..<br><br> - Life expectancy of 12 weeks or more.<br><br> - Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status<br> (PS) of 0 to 2.<br><br> - Males with fertility and females of childbearing potential are willing to use a<br> highly effective method of contraception for the entire study period and for 6<br> months after study drug discontinuation. Females of childbearing age, including<br> premenopausal females and within 2 years after menopause, must have a negative serum<br> pregnancy test result within 7 days prior to the first dose of study treatment.<br><br> - Subjects who had a voluntary agreement to provide written informed consent and the<br> willingness and ability to comply with all aspects of the protocol.<br><br>Exclusion Criteria:<br><br> - Patients with any of the following criteria were excluded from participation in this<br> study:<br><br> - Inadequate liver function:Albumin (ALB) < 25 g/L, or total bilirubin > 5 × the<br> upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline<br> phosphatase (ALP), or alanine aminotransferase (ALT) >10 × ULN.<br><br> - Inadequate renal function defined as creatinine >1.5 × ULN or calculated<br> creatinine clearance < 40 mL/min.<br><br> - Absolute neutrophil count (ANC) < 1.0×109/L, or Platelets < 30×109/L, or<br> Hemoglobin < 8.5 g/dL.<br><br> - International normalized ratio (INR) > 2.3.<br><br> - Poorly controlled hypertension, diabetes or other serious heart or lung<br> diseases, or with serious dysfunction.<br><br> - Patients who have received local or systemic anti-tumor treatments such as<br> ablation, Transhepatic Arterial Chemotherapy and Embolization (TACE), local<br> radiotherapy of the liver, immunotherapy, targeted therapy, etc., within 4<br> weeks, or chemotherapy, other trial drugs, or radiotherapy of metastatic<br> lesions within 2 weeks, except for treatment regimens assessed as disease<br> progression according to mRECIST or RECIST 1.1.<br><br> - Patients with uncurable brain metastasis.<br><br> - All toxicities related to prior locoregional or systemic anti-tumor treatments<br> are still grade 2 or more (except for hair loss and other events that have been<br> judged tolerable by researchers).<br><br> - Complication histories of liver cirrhosis or HCC such as gastrointestinal<br> hemorrhage, overt hepatic encephalopathy, or refractory ascites within 2 weeks<br> prior to the first dose of study treatment.<br><br> - Uncontrolled active infection (eg, lung infections, or abdominal infections).<br><br> - History of malignancy other than HCC within 5 years prior to screening, with<br> the exception of malignancies with a negligible risk of metastasis or death<br> (e.g., 5-year overall survival rate > 90%), such as adequately treated early<br> gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin<br> carcinoma, or localized prostate cancer.<br><br> - Hepatitis B virus DNA greater than 500 copies/mL, or hepatitis C virus RNA<br> greater than 15 U/mL.<br><br> - Positive for human immunodeficiency virus (HIV).<br><br> - Allergic to contrast agents.<br><br> - Pregnant/lactating women, or women with the possibility of pregnancy.<br><br> - Any medical conditions which, in the opinion of the investigator, would<br> preclude participation in this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- Secondary Outcome Measures
Name Time Method Objective Response Rate;Duration Of Response;Progression-Free Survival;Time To Progression;Time To Response;Disease Control Rate;Clinical Benefit Rate;Overall Survival;Patient Reported Outcome-1;Patient Reported Outcome-2;Patient Reported Outcome-3;The changes in tumor markers after treatment.