Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): problem of sponsor
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, Cisplatin, and Nab-Paclitaxe | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, Cisplatin, and Nab-Paclitaxel
- description
- * 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
- interventionNames
- Drug: Gemcitabine, Cisplatin, and Nab-Paclitaxe
Primary outcomes (1)
- measure
- Increased rate of RO resection
- timeFrame
- 16weeks
Secondary outcomes (1)
- measure
- the radiological response rate
- timeFrame
- 8weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available