A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk IHCC in Korea

NCT04546828 | Withdrawn Phase 2

• 1 other identifier: 2020-05-007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Phase of Development: II
2. 2.Patient Population: Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma
3. 3.Estimated Number of Patients: 34 patients
4. 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. 5.Secondary Objectives:

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Increased rate of RO resection

  16weeks

Secondary Outcomes (1)

• the radiological response rate

  8weeks

Study Arms (1)

Gemcitabine, Cisplatin, and Nab-Paclitaxel

EXPERIMENTAL

* 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

Drug: Gemcitabine, Cisplatin, and Nab-Paclitaxe

Interventions

Gemcitabine, Cisplatin, and Nab-Paclitaxe DRUG

* 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 .

Gemcitabine, Cisplatin, and Nab-Paclitaxel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Albumin ≥3 g/dl

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: February 1, 2021
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: June 15, 2022

Record last verified: 2022-06