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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04546828
Other study ID # 2020-05-007
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date February 1, 2021
Est. completion date August 18, 2021

Study information

Verified date June 2022
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Phase of Development: II 2. Patient Population: Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma 3. Estimated Number of Patients: 34 patients 4. Primary Objective: To assess the resetability of neoadjuvant chemotherapy including gemcitabine, cisplatin, and nab-paclitaxel for resectable oncologically high-risk intrahepatic cholangiocarcinoma that is treated with surgical resection. Thus, the primary aim is to increase R0 resection rate via completion of all treatment 5. Secondary Objectives: 1) To assess the radiological response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 2) To determine the overall resection rate 3) To determine recurrence-free survival (RFS) 4) To identify patients' overall survival (OS) rate. 5) Saftey and tolerability 6.Exploratory Endpoint : QoL analysis via EORTC QLO C-30


Description:

This is a multi-institution, open label phase II study designed to investigate the feasibility of gemcitabine/cisplatin/nab-paclitaxel as a neoadjuvant systemic chemotherapy for patients with reseactable oncologically high-risk IHCCA. This study will enroll up to 34 patients from all participating institutions with an accrual rate of 2 patients per month. This will be an open-label, single arm study with each cycle equal to 21 days. All three drugs will be administered intravenously on day 1 and day 8 of each cycle. Dosing will be calculated using body surface area (BSA) based on the actual weight of the patient at each visit. Nab-Paclitaxel will be given at 100 mg/m2, followed by cisplatin at 25 mg/m2 and then gemcitabine at 800 mg/m2 for 2 weeks in a row followed by a week of rest. Patients will receive 4 cycles of neoadjuvant systemic chemotherapy. Restaging will be done after every 2 cycles (+/- 1 week) by radiological imaging. If radiological scans demonstrate stable disease or partial or complete tumor response and the tumor remains resectable, surgery will be performed. For patients with radiological scans that document disease progression during the study, treatment will be discontinued off the protocol and will not be evaluable for other secondary endpoints. Resection will be performed per standard of care and will include a portal lymphadenectomy for all cases. Objective evidence of recurrent disease after resection will be recorded at the time of recurrence. Patients will be followed for overall survival endpoint as well.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 18, 2021
Est. primary completion date August 18, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of intrahepatic cholangiocarcinoma 2. Oncologic high-risk disease at the time of enrollment defined as T-stage = Ib (Ib - IV) Solitary lesion > 5 cm 3. Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable 4. Presence of major vascular invasion but still technically resectable 5. Suspicious or involved regional lymph nodes (N1) 6. No distant extrahepatic disease (M0) 7. High-quality cross-sectional imaging (CT or MRI) performed within 4 weeks prior to enrollment 8. Adults >18 years of age 9. Able to give informed consent 10. Able to adhere to study visit schedule and other protocol requirements 11. ECOG performance status of 0-1 12. Absolute neutrophil count = 1500/mm3 13Platelet count = 100,000/mm3 14.Albumin =3 g/dl Exclusion Criteria: - Serum creatinine > 1.5x upper limit of normal - Serum total bilirubin > 1.5x upper limit of normal - Presence of active infection - Pregnant and/or breastfeeding - Active other primary malignancy - Concurrent severe and/or uncontrolled medication conditions which could compromise participation in study such as unstable angina, MI within 6 months, unstable symptomatic arrhythmia, symptomatic CHF, serious active or uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gemcitabine, Cisplatin, and Nab-Paclitaxe
Nab-paclitaxel 100mg/m2 in NS dilute to a total concentration of 5 mg/mL (DO NOT FILTER) over 30 minute IV infusion on days 1 and 8 repeated every 21 days, followed by: Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days, followed by: Gemcitabine 800 mg/m2 in 500ml over 30 minute IV infusion on days 1 and 8 repeated every 21 days .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Increased rate of RO resection 16weeks
Secondary the radiological response rate To assess the radiological response rate according to Response Evaluation Criteria in Solid Tumors 8weeks
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