Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07570849

Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma

Led by Shanghai Zhongshan Hospital · Updated on 2026-05-06

35

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. All participants will receive chidamide, an oral HDAC inhibitor, in combination with gemcitabine, cisplatin, and an immune checkpoint inhibitor. Treatment will be administered in 21-day cycles until disease progression, unacceptable toxicity, or other withdrawal criteria are met. The primary study endpoints are objective response rate (ORR), and safety, evaluated by the frequency and severity of adverse events. Secondary endpoints include progression-free survival (PFS), duration of response (DOR), overall survival (OS), and exploratory biomarker analyses. The study aims to assess whether the addition of chidamide to standard chemotherapy and immunotherapy can improve treatment outcomes in this patient population.

CONDITIONS

Official Title

Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent and willing to complete all study procedures
  • Male or female aged 18 to 75 years
  • Histologically or pathologically confirmed unresectable or metastatic intrahepatic cholangiocarcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Laboratory values within 7 days prior to treatment: neutrophils  1.5  10/L, platelets  50  10/L, hemoglobin  90 g/L without recent transfusion, serum creatinine  1.5  upper limit normal, creatinine clearance  50 mL/min, AST and ALT  2.5  upper limit normal, serum albumin  30 g/L, INR and aPTT within defined limits based on anticoagulation status, serum bilirubin  1.25  upper limit normal
  • Life expectancy of at least 12 weeks
  • At least one measurable lesion confirmed by RECIST version 1.1
  • Controlled hepatitis B patients meeting defined antiviral therapy and viral load criteria
  • Good compliance with study requirements
Not Eligible

You will not qualify if you...

  • Prior treatment with a histone deacetylase (HDAC) inhibitor
  • Active autoimmune disease requiring systemic treatment within past 2 years (except psoriasis)
  • Planned major surgery during study or screening period
  • History of interstitial lung disease or pneumonitis requiring corticosteroids
  • Known HIV infection, immunodeficiency disorders, or history of organ/stem cell transplant
  • Significant liver disease including active viral hepatitis or severe cirrhosis
  • Allergy to study drugs or monoclonal antibodies used in this trial
  • Participation in another investigational drug trial within 4 weeks
  • Receipt of live vaccine within 30 days prior to treatment
  • Recent local liver therapy or radiotherapy outside liver within defined timeframes
  • Additional malignancy requiring active treatment within past 3 years
  • History of alcohol, drug, or substance abuse within past year
  • Pregnant, breastfeeding, or planning pregnancy during study
  • Any condition interfering with study participation or safety as judged by investigator
  • Investigator deems patient unsuitable for trial participation for any other reason

AI-Screening

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Trial Site Locations

Total: 1 location

1

180 Fenglin Road

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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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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