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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Gemcitabine

Criteria

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.