- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077983
Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
September 3, 2019 updated by: Shanghai Zhongshan Hospital
a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Most patients with intrahepatic cholangiocarcinoma (ICC) are often accompanied by local or distant metastases and lose the opportunity for surgical resection.
Surgical resection is the only effective means for long-term survival of patients with intrahepatic cholangiocarcinoma.
However, multiple tumors, lymph node metastasis, and vascular invasion significantly reduced postoperative survival.
Most patients will relapse due to less clinical data.
The best adjuvant treatment strategy and standard protocol for patients with intrahepatic cholangiocarcinoma has not been determined.
Current treatment options include chemotherapy based on fluoropyrimidine or gemcitabine.
Albumin-bound paclitaxel(nab-paclitaxel) has been used to treat a variety of malignancies such as non-small cell lung cancer, pancreatic cancer, breast cancer, melanoma, ovarian cancer and the like.
In the field of pancreatic cancer, studies have confirmed that albumin-bound paclitaxel has synergistic effects with gemcitabine.
The combination of gemcitabine alone significantly increased the intratumoral concentration of gemcitabine.
Albumin-bound paclitaxel plus gemcitabine is the first choice for first-line treatment of pancreatic cancer, but clinical studies in the field of cholangiocarcinoma are very limited.
Based on the same origin of pancreatic and biliary embryos, biological behavior and pathological similarities.
Therefore, in this second phase of the study, our aim was to evaluate the efficacy and safety of chemotherapy with nab-paclitaxel and gemcitabine in the prevention of postoperative recurrence in patients with intrahepatic cholangiocarcinoma.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: qi-man sun, MD
- Phone Number: +8618616882028
- Email: sun.qiman@zs-hospital.sh.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: combined therapy using nab-paclitaxel and gemcitabine chemo
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival
Time Frame: 24 months
|
the time from the day after surgery to the recurrence of cancer.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety: the potential side effects
Time Frame: 6 months
|
the potential side effects
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 24 months
|
the time from the day after surgery to death
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Clin Cancer Res. 2006 Jun 15;12(12):3869. Dosage error in article text.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2019
Primary Completion (ANTICIPATED)
September 1, 2020
Study Completion (ANTICIPATED)
September 1, 2022
Study Registration Dates
First Submitted
September 1, 2019
First Submitted That Met QC Criteria
September 3, 2019
First Posted (ACTUAL)
September 4, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 3, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Cholangiocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- ICC-afterresection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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