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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT07570849
What this study is testing
What is Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor?
Chidamide, Gemcitabine, cisplatin, immune checkpoint inhibitor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Also referred to as Chidamide + Gemcitabine + cisplatin + immune checkpoint inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label, phase II clinical trial designed to evaluate the efficacy and safety of chidamide in combination with chemotherapy and immunotherapy as a first-line treatment for patients with advanced intrahepatic cholangiocarcinoma (ICC), a type of liver cancer. The study will enroll approximately 35 patients with histologically or pathologically confirmed unresectable or metastatic ICC who have not received prior systemic therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial...
- Male or female, aged 18 to 75 years.
- Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory test values within 7 days prior to the start of treatment must meet the following criteria:
You likely can't join if
- 1\. Prior treatment with a histone deacetylase (HDAC) inhibitor. 2. Has an active autoimmune disease (with the exception of psoriasis) that has...
- 3\. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major...
- 4\. Known history of interstitial lung disease or has non-infectious pneumonitis requiring corticosteroid treatment.
- 5\. Known history of human immunodeficiency virus (HIV) infection, other acquired or congenital immunodeficiency disorders, or a history of organ...
- 6\. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, or other hepatitis; severe cirrhosis, fatty...
- 7\. Known history of allergy to macromolecular protein preparations/monoclonal antibodies or to the chemotherapeutic agents used in this trial.
See the full eligibility criteria
- Voluntarily sign the informed consent form (ICF), fully understand the study, and be willing to comply with and capable of completing all trial procedures.
- Male or female, aged 18 to 75 years.
- Patients with histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma (ICC). Patients with extrahepatic cholangiocarcinoma (EHCC) or gallbladder cancer (GBC) are excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory test values within 7 days prior to the start of treatment must meet the following criteria:
- Neutrophils ≥ 1.5 × 10⁹/L;
- Platelets ≥ 50 × 10⁹/L;
- Hemoglobin ≥ 90 g/L (without packed red blood cell transfusion within the past 2 weeks);
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL/min;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- Serum albumin ≥ 30 g/L;
- For patients not receiving anticoagulation therapy: INR or aPTT ≤ 1.5 × ULN. Patients receiving prophylactic anticoagulation are eligible if INR ≤ 2 × ULN and aPTT is within the normal range within 14 days prior to the...
- Serum bilirubin ≤ 1.25 × ULN.
- Life expectancy ≥ 12 weeks.
- Presence of at least one measurable lesion as confirmed by RECIST version 1.1.
- Patients with controlled hepatitis B are eligible if they meet the following criteria: HBV antiviral therapy must have been administered for at least 4 weeks, and HBV viral load must be less than 100 IU/mL prior to the...
- Patients must have good compliance.
- 1\. Prior treatment with a histone deacetylase (HDAC) inhibitor. 2. Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment within the past 2 years (i.e., use of...
- 3\. Anticipated major surgery during the study period, including the 28-day screening period (diagnostic surgical procedures are excluded). Major surgery is defined as a procedure requiring at least 3 weeks of recovery...
- 4\. Known history of interstitial lung disease or has non-infectious pneumonitis requiring corticosteroid treatment.
- 5\. Known history of human immunodeficiency virus (HIV) infection, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or stem cell transplantation.
- 6\. Known clinically significant liver disease, including active viral hepatitis, alcoholic hepatitis, or other hepatitis; severe cirrhosis, fatty liver, hereditary liver disease, liver atrophy, portal hypertension...
- 7\. Known history of allergy to macromolecular protein preparations/monoclonal antibodies or to the chemotherapeutic agents used in this trial.
- 8\. Participation in another clinical trial of an investigational drug within 4 weeks prior to the first dose of study drug (calculated from the last use of the investigational drug).
- 9\. Receipt of a live vaccine within 30 days prior to the first dose of study drug. Inactivated virus vaccines for seasonal influenza are permitted; however, intranasally administered live attenuated influenza vaccines...
- 10\. Received prior local therapy to the liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization, or ablation) within 4 weeks prior to the first...
- 11\. Received prior radiotherapy to non-hepatic regions within 2 weeks prior to the first dose of study drug. Patients must have recovered from all radiotherapy-related toxicities, not require corticosteroids, and have...
- 12\. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in...
- 13\. History of alcohol dependence, or history of drug abuse or substance abuse within the past 1 year.
- 14\. Is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period, from the screening visit through 120 days after the last dose of study treatment.
- 15\. Has any condition (e.g., disease history or evidence, treatment, laboratory abnormality) that, in the investigator's judgment, could interfere with the trial results, preclude the patient's full participation in...
- 16\. Patients deemed by the investigator to be unsuitable for participation in this trial for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.