- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546828
A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea
A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in Korea
- Phase of Development: II
- Patient Population: Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma
- Estimated Number of Patients: 34 patients
- 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
- 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of intrahepatic cholangiocarcinoma
- Oncologic high-risk disease at the time of enrollment defined as T-stage ≥ Ib (Ib - IV) Solitary lesion > 5 cm
- Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable
- Presence of major vascular invasion but still technically resectable
- Suspicious or involved regional lymph nodes (N1)
- No distant extrahepatic disease (M0)
- High-quality cross-sectional imaging (CT or MRI) performed within 4 weeks prior to enrollment
- Adults >18 years of age
- Able to give informed consent
- Able to adhere to study visit schedule and other protocol requirements
- ECOG performance status of 0-1
- 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 Plan
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: Gemcitabine, Cisplatin, and Nab-Paclitaxel
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increased rate of RO resection
Time Frame: 16weeks
|
16weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the radiological response rate
Time Frame: 8weeks
|
To assess the radiological response rate according to Response Evaluation Criteria in Solid Tumors
|
8weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Cholangiocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- 2020-05-007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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