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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03772132
Other study ID # DLY20181206
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 2016
Est. completion date December 2021

Study information

Verified date December 2018
Source Shanghai Jiao Tong University School of Medicine
Contact yingbin liu, PHD
Phone +86 13918803900
Email laoniulyb@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.


Description:

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- • Chinese;

- Stable vital signs, KPS=60;

- Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;

- Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;

- At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;

- Life expectancy of more than 12 weeks;

- Adequate hepatic, hematologic and renal functions(ALT=10×upper limit of normal (ULN), AST=10×ULN, the Child-Pugh classification for class A or B, white blood cells=3×10^9/L, neutrophils=1.5×10^9/L, platelets=80×10^9/L , hemoglobin = 90g/L, creatinine clearance rate=60ml/min;

- Volunteer for this study, have written informed consent and have good Patient compliance;

- Female patients of childbearing potential and their mates agree to avoid pregnancy.

Exclusion Criteria:

- Have received following treatment before this study:

1. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;

2. lesions have been treated by irradiation;

3. participate in other therapeutic or interventional clinical trials. - Page 5 of 5 [DRAFT] -

- Have central nervous system metastasis;

- History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;

- Have symptomatic ascites and need for treatment;

- Have serious concurrent illness including, but not limited to

1. uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);

2. ongoing or active serious infection;

3. uncontrolled diabetes mellitus;

4. psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;

5. HIV infection;

6. other serious illness considered not suitable for this study by investigators.

- be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
mutation and signal pathway activation status analysis Drug: FORFIRINOX
Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy

Locations

Country Name City State
China Xinhua Hospital Shanghai Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Eastern Hepatobiliary Surgery Hospital, Huashan Hospital, RenJi Hospital, Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors. up to 1 year
Secondary Overall survival up to 2 years
Secondary Objective Response Rate Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment, consistent with RECIST version 1.1 criteria for solid tumors. up to 1 year
Secondary Disease Control Rate Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors. up to 1 year
Secondary percentage of patients with Clinical Benefit Response Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.
Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
up to 1 year
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