Chemotherapy FOLFIRINOX in Advanced or Recurrent Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 100
• Participant gender: All

Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of FOLFIRINOX in advanced or recurrent cholangiocarcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Folfirinox

Criteria

Inclusion Criteria:

• Chinese;

• Stable vital signs, KPS≥70;

• Patients have a diagnosis of advanced or recurrent metastatic cholangiocarcinoma by histopathology or cytopathology;、 visceral measurable metastases (at least one lesion>10 mm) and/or measurable and non-resectable primary tumor.

• 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≥75×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min，Prothrombin rate ≥70%；

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

Exclusion Criteria:

• Recived Anti-tumor molecular target therapy; anti-tumor chemotherapy in 4 months; lesions have been treated by irradiation; participate in other therapeutic or interventional clinical trials.

• Have central nervous system metastasis;

• History of other malignancies；

• 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.