First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC

June 19, 2025 updated by: Jinbo Yue, Shandong Cancer Hospital and Institute

A Single-arm, Exploratory Phase II Clinical Trial of Combined Radiotherapy and HAIC as First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma

The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Intrahepatic cholangiocarcinoma (ICC) ranks as the second most common primary liver cancer, constituting 15%-20% of malignant liver tumors, with a rising incidence trend. Unlike hepatocellular carcinoma (HCC), ICC displays higher invasiveness and metastatic potential. Surgical resection remains the optimal treatment, yet many patients present with unresectable disease or metastasis, limiting surgical options. Chemotherapy, particularly the GC regimen, is standard for unresectable and metastatic ICC. Studies like ABC-02 have improved survival with GC chemotherapy compared to gemcitabine monotherapy. However, the median survival remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Jinbo Yue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-75 years, both male and female.
  • Histologically or cytologically confirmed primary cholangiocarcinoma (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and gallbladder carcinoma) or imaging-confirmed localized cholangiocarcinoma, staged as T1-4N0/N+M0 (according to AJCC 7th edition clinical staging).
  • Ineligible for surgical treatment or refusal of surgical treatment upon pre-treatment assessment.
  • Presence of measurable lesions as per RECIST v1.1 criteria for evaluation.
  • ECOG performance status: 0-1.
  • Expected survival of more than 6 months.
  • Tolerable function of major organs for treatment.
  • Non-surgically sterilized or premenopausal female patients need to use a medically accepted contraceptive method during the study treatment period and within 3 months after the end of the study treatment.

Exclusion Criteria:

  • Subjects with any active autoimmune disease or a history of autoimmune disease are excluded.

  • Patients with poorly controlled clinical symptoms or diseases related to the heart, such as:

    1. NYHA Class 2 or above heart failure
    2. Unstable angina
    3. Myocardial infarction within the past year
    4. Clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention
    5. QTc >450 ms (males); QTc >470 ms (females)
  • Abnormal coagulation function (INR >1.5 or PT >16s), bleeding tendencies, or receiving thrombolytic or anticoagulant therapy.
  • Subjects who have received radiation therapy, chemotherapy, steroid therapy, surgery, or molecular targeted therapy within less than 4 weeks (or 5 half-lives of the drug, whichever is longer) before the study drug's first dose, or who have not recovered from adverse events caused by previous treatment (excluding alopecia) to ≤Grade 1 according to CTCAE.
  • Subjects with clinically symptomatic ascites, pleural effusion, or pericardial effusion requiring therapeutic puncture or drainage. Those who have had stable ascites or effusion after drainage of pleural or pericardial effusion for at least 2 weeks before the first dose of the study drug can be included in the study.
  • Subjects with significant hemoptysis in the last 2 months or hemoptysis of half a teaspoon (2.5 ml) or more.
  • Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophiliacs, coagulation disorders, thrombocytopenia, splenomegaly, etc.) or those who have had arterial or venous thrombotic events within the last 6 months (prior to first SHR-1210 administration).
  • Subjects with active infections or unexplained fever >38.5°C during screening or before the first dose of the study drug.
  • Patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment, etc., either historically or currently.
  • Subjects with congenital or acquired immunodeficiency (such as HIV infection) or active hepatitis (HBV reference: HBV DNA test value exceeds the upper limit of normal; HCV reference: HCV virus titer or RNA test value exceeds the upper limit of normal).
  • Use of other investigational drugs within 4 weeks prior to the first dose of the study drug.
  • Subjects with a history of or concurrent other malignancies (excluding cured basal cell carcinoma and cervical carcinoma in situ).
  • Subjects who may receive other systemic anti-tumor therapies during the study.
  • Subjects who have previously received PD-1 antibody therapy or immune therapy targeting PD-1/PD-L1.
  • Vaccination with live vaccines within less than 4 weeks before the study drug's administration or potentially during the study period.
  • Other factors judged by the investigator that may necessitate premature termination of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy plus HAIC
Radiotherapy + Hepatic Arterial Infusion Chemotherapy (Gesitabine) + Chemotherapy (GEMOX)
Radiation: Radiotherapy
Radiotherapy + Hepatic Arterial Infusion Chemotherapy (Gesitabine) + Chemotherapy (GEMOX)
Other Names:
  • Hepatic Arterial Infusion Chemotherapy (GEMOX)
  • Chemotherapy (Gesitabine)
Drug: HAIC (GEMOX)
Hepatic Arterial Infusion Chemotherapy (GEMOX)
Other Names:
  • HAIC
Drug: Chemotherapy
Chemotherapy (Gesitabine)
Other Names:
  • Chemotherapy (Gesitabine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 2 year
Assessing the severity of adverse events according to CTCAE v4.0.3 standards.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 2 year
the length of time during and after treatment with a medication or therapy that a patient lives with the disease without it progressing
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Jin Bo Yue, Dr., Shandong Cancer Hospital and Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

April 6, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 19, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDZLEC2023-109-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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