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

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

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:

  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.

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
  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.
  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.

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.

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.

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

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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