Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

NCT03772132 | Unknown Phase 2

• 1 other identifier: DLY20181206
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangiocarcinoma of the Extrahepatic Bile Duct; Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival

  up to 2 years

• Objective Response Rate

  up to 1 year

• Disease Control Rate

  up to 1 year

• percentage of patients with Clinical Benefit Response

  up to 1 year

Study Arms (1)

Chemotherapy

EXPERIMENTAL

The patients wil receive conventional chemotherapy FORFIRINOX

Biological: mutation and signal pathway activation status analysis Drug: FORFIRINOX

Interventions

mutation and signal pathway activation status analysis Drug: FORFIRINOX BIOLOGICAL

Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have received following treatment before this study:
• Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
• lesions have been treated by irradiation;
• 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
• 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);
• ongoing or active serious infection;
• uncontrolled diabetes mellitus;
• psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
• HIV infection;
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Ruijin Hospital: collaborator
• RenJi Hospital: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Mutation

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena

Study Officials

• yingbin liu, PHD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yingbin liu, PHD

CONTACT

+86 13918803900; laoniulyb@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of general surgery department，xin hua Hospital Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: July 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

CN (1)