Our Goal

To change the approach to treating ICC by harnessing the power of liver directed therapy

Disease Focus

Intra-hepatic cholangiocarcinoma (ICC) is a cancer that originates in the bile duct issue within the liver. ICC is the second most common primary liver tumor and accounts for 3% of all gastrointestinal cancers and 15% of HCC cases diagnosed in the U.S. and Europe annually.

ALIGN Phase 3 Global Clinical Trial – Enrolling Now

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Study Title

Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine in Patients with Intrahepatic Cholangiocarcinoma

Study objective

This study will evaluate two groups of patients who have intrahepatic cholangiocarcinoma. Each group will receive induction treatment with Cisplatin and Gemcitabine per standard of care for 4 treatment cycles. Following induction treatment patients will be randomly assigned to either 1 of 2 arms of treatment. One group (50%) will be receive high dose chemotherapy delivered specifically to the liver (Melphalan/HDS), while the other group (50%) will continue treatment with Cisplatin and Gemcitabine. Patient in each group will get repeating cycles of treatment until the cancer advances. All patients will be followed until death. This study will compare the overall survival (OS) in patients with intrahepatic cholangiocarcinoma

Who is Eligible?

  • Patients who are willing and able to provide signed informed consent
  • Intrahepatic cholangiocarcinoma diagnosed by histology (laboratory tests)
  • ICC which is inoperable, with less than 50% of the liver involved, and without clinically significant extra-hepatic disease
  • Scans used to determine eligibility (CT scan of the chest/abdomen/pelvis and liver) must be performed within 28 days prior to initiation of treatment
  • At least one target lesion based on the evaluation criteria in solid tumors (RECIST 1.1)
  • Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Score) of 0-1 at screening
  • Male or female patients aged ≥ 18 years.
  • Patients must weigh ≥ 35 kg

Exclusion Criteria:

A number of scans, laboratory tests and general fitness tests must be carried out in order to determine the suitability of patients going forward for the trial. Previous treatments will be considered as well as tumor burden, childbearing potential, underlying cardiac conditions, underlying infections, history of bleeding disorders and a detailed picture of the candidate’s liver function, as well as a number of other factors to be considered before the patient is recruited into the trial.

Interested patients should consult with a healthcare professional to see if you meet the entry criteria. For further information on inclusion and exclusion criteria please click here.

What Will Happen During the Trial?

If you qualify for and decide to participate in the ALIGN trial, additional requirements are:

  • In the first 12 weeks of the study you will receive 4 cycles of cisplatin/gemcitabine
  • All patients will have imaging scans done between treatments at the hospital
  • Patients who have at least stable disease via imaging at the end of the initial induction phase will be randomly assigned in n a 1:1 ratio to Melphalan/HDS treatment or to continue cisplatin/gemcitabine, until progressive disease (PD) or unacceptable toxicity is observed
  • For patients selected for Melphalan/HDS, you will receive treatment about every 6 weeks for up to 6 treatments and stay in the hospital for up to 3 days each time
  • All patients will get blood work done between treatments at the hospital.
  • All patients will be evaluated by CAT scans or MRIs to determine cancer status every 10-14 weeks.
  • After the Melphalan/HDS treatment, in the absence of disease progression, the patient should undergo a re-induction of cisplatin/gemcitabine.
  • Tumor response will be assessed in both treatment arms every 8 weeks (+ 1 week) until progressive disease

For more information about patient eligibility and participating centers, please contact our Medical Affairs department at medicalaffairs@delath.com

Where is the treatment available?

The ALIGN Trial is currently being conducted at leading cancer institutes worldwide. Click on the interactive map below to view the locations or to find out more email medaffairgroup@delcath.com

ALIGN Trial Locations