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

Primary Purpose

Cholangiocarcinoma, Intrahepatic

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

combined therapy using nab-paclitaxel and gemcitabine chemotherapy

About this trial

This is an interventional prevention trial for Cholangiocarcinoma, Intrahepatic focused on measuring intrahepatic cholangiocarcinoma, nab-paclitaxel and gemcitabine chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combined therapy using nab-paclitaxel and gemcitabine chemo

Arm Description

Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2 Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2 Three weeks is a course of treatment with a total of 4 courses.

Outcomes

Primary Outcome Measures

Disease-free survival

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

Secondary Outcome Measures

safety: the potential side effects

the potential side effects

Full Information

NCT ID

NCT04077983

First Posted

September 1, 2019

Last Updated

September 3, 2019

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04077983

Brief Title

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

Official Title

a Single-arm Study of Nab-Paclitaxel Combined With Gemcitabine Adjuvant Chemotherapy After Radical Resection of Intrahepatic Cholangiocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Anticipated)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholangiocarcinoma, Intrahepatic

Keywords

intrahepatic cholangiocarcinoma, nab-paclitaxel and gemcitabine chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

combined therapy using nab-paclitaxel and gemcitabine chemo

Arm Type

Experimental

Arm Description

Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2 Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2 Three weeks is a course of treatment with a total of 4 courses.

Intervention Type

Drug

Intervention Name(s)

combined therapy using nab-paclitaxel and gemcitabine chemotherapy

Intervention Description

Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2 Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2 Three weeks is a course of treatment with a total of 4 courses.

Primary Outcome Measure Information:

Title

Disease-free survival

Description

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

Time Frame

24 months

Secondary Outcome Measure Information:

Title

safety: the potential side effects

Description

the potential side effects

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

overall survival

Description

the time from the day after surgery to death

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

qi-man sun, MD

Phone

+8618616882028

sun.qiman@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Guo-Ming Shi, MD

Phone

+8613916969578

shi.guoming@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Zhou, MD&PhD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16489089

Citation

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.

Results Reference

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PubMed Identifier

22585996

Citation

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.

Results Reference

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PubMed Identifier

21969517

Citation

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.

Results Reference

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

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