Combining radiotherapy and chemotherapy for advanced bile duct cancer

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

This study is testing a new treatment that combines chemotherapy and radiation for patients with advanced bile duct cancer who can't have surgery to see if it helps them feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shandong Cancer Hospital and Institute (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06370663 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a new treatment approach for unresectable intrahepatic cholangiocarcinoma by combining hepatic arterial infusion chemotherapy (HAIC) with radiotherapy. The study aims to assess the safety and efficacy of this combination, utilizing a fluoropyrimidine-based regimen alongside gemcitabine infusion. It is a single-center, single-arm trial that focuses on patients who are not candidates for surgical intervention. The goal is to explore the potential benefits of this synergistic treatment strategy and identify molecular predictors of response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed unresectable intrahepatic cholangiocarcinoma and measurable lesions.

Not a fit: Patients with active autoimmune diseases or those who are not eligible for the treatment due to poor organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced bile duct cancer.

How similar studies have performed: While there is limited research on this specific combination, previous studies have shown promise for HAIC in cholangiocarcinoma treatment, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Jinbo Yue — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Jin Bo Yue, Dr. — Shandong Cancer Hospital and Institute
• Study coordinator: Jin Bo Yue, Dr.

Conditions Intrahepatic Cholangiocarcinoma; Radiotherapy; Hepatic Arterial Infusion Chemotherapy