Advanced Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.
Detailed description
Primary Objective: To assess the overall survival of patients treated with standard of care systemic therapy with or without liver-directed hypofractionated adaptive RT. Secondary Objectives: * Patient-reported quality of life as per the FACT-Hep inventory * Progression-free survival * Cause of death
Interventions
DRUGDurvalumab
Given by IV
DRUGGemcitabine
Given by IV
DRUGCisplatin
Given by IV
Sponsors
M.D. Anderson Cancer Center
AstraZeneca
Varian Medical Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients older than the age of 18 years old at the time of study entry. 2. Patients with a body mass greater than 30 kg. 3. Patients with a pathological diagnosis of intrahepatic cholangiocarcinoma and at least one intrahepatic tumor measuring 3 cm in greatest dimension 4. Patients must have pathological or radiographic evidence of either: c. locally advanced unresectable iCCA - a multidisciplinary discussion should be documented for patients who have liver confined disease, confirming that the patient is not resectable. d. extrahepatic metastasis at the time of enrollment - allowable extrahepatic metastases may include disease in non-regional lymph nodes (note that metastatic involvement of regional lymph nodes in the hilum of the liver alone do not qualify as M1 disease), lung, and/or bone. 5. Patients should receive at least 4 cycles of systemic therapy with gemcitabine/cisplatin with durvalumab. If one of the drugs (gemcitabine/cisplatin/durvalumab) was held at any point for medical reasons during the initial 4 cycles, the patient is still eligible as long as the treating team agrees about the ability of the patient to continue systemic therapy. 6. Patients must be appropriate candidates for radiation therapy with adequate liver function, at the discretion of the treating physician. 7. A patient may pre-register at any time before cycle 4 of systemic therapy. To be eligible to pre-register for the trial, they must meet all other inclusion and
Exclusion criteria
, except criteria number 5 regarding the number of cycles of systemic therapy.Pre-registration is not required to enroll. 8. Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1.0 × 109 /L Platelet count ≥75 × 109/L Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL) 9. Must have a life expectancy of at least 12 weeks 10. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization 11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTEugene Koay, MD,PHD
PRINCIPAL_INVESTIGATOREugene Koay, MD,PHD
M.D. Anderson Cancer Center
Outcome results
None listed