Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma

NCT04077983 | Unknown Phase 2

• 1 other identifier: ICC-afterresection
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Cholangiocarcinoma, Intrahepatic

Keywords

intrahepatic cholangiocarcinoma; nab-paclitaxel and gemcitabine chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  the time from the day after surgery to the recurrence of cancer.

  24 months

Secondary Outcomes (1)

• safety: the potential side effects

  6 months

Other Outcomes (1)

• overall survival

  24 months

Study Arms (1)

combined therapy using nab-paclitaxel and gemcitabine chemo

EXPERIMENTAL

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.

Drug: combined therapy using nab-paclitaxel and gemcitabine chemotherapy

Interventions

combined therapy using nab-paclitaxel and gemcitabine chemotherapy DRUG

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.

combined therapy using nab-paclitaxel and gemcitabine chemo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have good compliance, be understood the research process of this study and required to sign an informed consent form;
• age 18-75 years old, male or female;
• Histopathologically confirmed intrahepatic cholangiocarcinoma，excluding mixed liver cancer;
• 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;
• Study treatment can be started within 4\~6 weeks after R0 resection;
• Except for R0 resection, no other anti-tumor treatment has been received;
• No distant transfer；
• ECOG\<2, or KPS\>70；
• Bone marrow function criteria: hemoglobin (HGB)≥90g/L; absolute neutrophil count (ANC)≥1.5×109/L; platelets (PLT)≥100×109/L;
• Liver function criteria: ALT, AST≤5×ULN, serum total bilirubin\<3×ULN;
• Renal function criteria: creatinine clearance \> 45 mL/min
• Prothrombin time \<14s; (no anticoagulant therapy);
• Patients without biliary obstruction who require biliary stent implantation must be completed at least 7 days prior to enrollment;
• Non-lactating or pregnant women, contraception during or after 6 months of treatment.
• No contraindications for gemcitabine and Nab-paclitaxel.

You may not qualify if:

• Those patients who are allergic to the chemotherapy drugs and their components in this study
• Patients with other malignant tumors within 5 years (except for cured carcinoma in situ or basal cell carcinoma of the skin)
• 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;
• Intraoperative or postoperative pathology determines patients who do not meet radical resection;
• Patients with current or previous ≥ grade II peripheral neuropathy;
• Patients who participated in other clinical studies within 4 weeks prior to enrollment;
• Patients who has undergone organ transplantation;
• Patients considered by the investigator not suitable for this trial.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Related Publications (3)

• Desai 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 BACKGROUND

• Frese 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 BACKGROUND

• Von 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 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Jian Zhou, MD&PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

qi-man sun, MD

CONTACT

+8618616882028; sun.qiman@zs-hospital.sh.cn

Guo-Ming Shi, MD

CONTACT

+8613916969578; shi.guoming@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2022
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share