Clinical trial · Interventional
Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
NCT04077983CI-TRIAL-00040389unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this phase 2 study, we aim to evaluate the effects and safety of combined therapy using nab-paclitaxel and gemcitabine chemotherapy for patients after radical resection of Intrahepatic Cholangiocarcinoma
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 |
|---|---|---|---|
| Cholangiocarcinoma, Intrahepatic | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| combined therapy using nab-paclitaxel and gemcitabine chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- combined therapy using nab-paclitaxel and gemcitabine chemo
- description
- 1. Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2 2. Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2 3. Three weeks is a course of treatment with a total of 4 courses.
- interventionNames
- Drug: combined therapy using nab-paclitaxel and gemcitabine chemotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 24 months
- description
- the time from the day after surgery to the recurrence of cancer.
Secondary outcomes (1)
- measure
- safety: the potential side effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient must have good compliance, be understood the research process of this study and required to sign an informed consent form; 2. age 18-75 years old, male or female; 3. Histopathologically confirmed intrahepatic cholangiocarcinoma,excluding mixed liver cancer; 4. The longest diameter of a single tumor in patients before surgery is 3\~9cm. If the number of multiple tumors is ≤3, the total diameter≤9cm, maximum diameter ≤5cm; 5. Study treatment can be started within 4\~6 weeks after R0 resection; 6. Except for R0 resection, no other anti-tumor treatment has been received; 7. No distant transfer; 8. ECOG\<2, or KPS\>70; 9. Bone marrow function criteria: hemoglobin (HGB)≥90g/L; absolute neutrophil count (ANC)≥1.5×109/L; platelets (PLT)≥100×109/L; 10. Liver function criteria: ALT, AST≤5×ULN, serum total bilirubin\<3×ULN; 11. Renal function criteria: creatinine clearance \> 45 mL/min 12. Prothrombin time \<14s; (no anticoagulant therapy); 13. Patients without biliary obstruction who require biliary stent implantation must be completed at least 7 days prior to enrollment; 14. Non-lactating or pregnant women, contraception during or after 6 months of treatment. 15. No contraindications for gemcitabine and Nab-paclitaxel. Exclusion Criteria: 1. Those patients who are allergic to the chemotherapy drugs and their components in this study 2. Patients with other malignant tumors within 5 years (except for cured carcinoma in situ or basal cell carcinoma of the skin) 3. Concomitant diseases that may interfere with treatment studies: such as severe infections, HIV-positive, clinically severe (ie active) Heart disease, uncontrolled epilepsy, central nervous system disease, or history of mental disorders; 4. Intraoperative or postoperative pathology determines patients who do not meet radical resection; 5. Patients with current or previous ≥ grade II peripheral neuropathy; 6. Patients who participated in other clinical studies within 4 weeks prior to enrollment; 7. Patients who has undergone organ transplantation; 8. Patients considered by the investigator not suitable for this trial.
References
Publications (3)
- BACKGROUNDDesai N, Trieu V, Yao Z, Louie L, Ci S, Yang A, Tao C, De T, Beals B, Dykes D, Noker P, Yao R, Labao E, Hawkins M, Soon-Shiong P. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006 Feb 15;12(4):1317-24. doi: 10.1158/1078-0432.CCR-05-1634. PMID 16489089
- BACKGROUNDFrese KK, Neesse A, Cook N, Bapiro TE, Lolkema MP, Jodrell DI, Tuveson DA. nab-Paclitaxel potentiates gemcitabine activity by reducing cytidine deaminase levels in a mouse model of pancreatic cancer. Cancer Discov. 2012 Mar;2(3):260-269. doi: 10.1158/2159-8290.CD-11-0242. Epub 2012 Feb 28. PMID 22585996
- BACKGROUNDVon Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3. PMID 21969517