intrahepatic cholangiocarcinomas, ICC
Conditions
Interventions
one:The hepatic artery catheter Folfox6 chemotherapy
two:Transcatheter arterial infusion chemotherapy after radical resection of ICC (Folfox 6 regimen)
three:Whole-body (gemcitabine-based regimen) in the treatment of patients with unresectable middle and late ICC
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University,
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. (Folfox 6 regimen) vs. Systemic (Folfox 6 regimen) vs. Systemic (gemcitabine-based regimen) as neoadjuvant chemotherapy for radical resection of ICC: (1) preoperative imaging examination clearly ICC diagnosis; pre-group liver biopsy, a clear diagnosis of ICC for malignant cholangiocarcinoma; (2) the tumor before the group staging late, not suitable for radical resection of the tumor; (3) preoperative systemic or liver function allows the implementation of hepatectomy; (4) before the group received no chemotherapy, interventional therapy contraindications. 2. after radical resection of ICC patients with hepatic arterial infusion chemotherapy (Folfox 6 program) vs. System (Folfox 6 program) vs. Systemic (gemcitabine-based program) as a prophylactic chemotherapy study: (1) preoperative diagnosis of malignant bile duct adenocarcinoma confirmed by surgical resection of the tumor; (2) before surgery to confirm the surgical excision margin R0 level; (3) no chemotherapy before admission, contraindication of interventional therapy; (4) In addition to surgical removal before admission, did not receive any radiotherapy and chemotherapy, interventional therapy and other anti-tumor therapy. 3. (Folfox 6 regimen) vs systemic (gemcitabine-based regimen) in the treatment of unresectable patients with advanced or late stage ICC in patients undergoing transcatheter arterial infusion chemotherapy (Folfox 6 regimen) vs systemic (Folfox 6 regimen): (1) pre-group liver biopsy histopathology confirmed the diagnosis of malignant bile duct adenocarcinoma; (2) Radiologic examination was confirmed as advanced ICC before radical resection; (3) no chemotherapy before admission, contraindication of interventional therapy; (4) before admission did not receive any radiotherapy and chemotherapy, interventional therapy and other anti-tumor therapy.
Exclusion criteria
Exclusion criteria: 1.(Folfox 6 regimen) vs the whole body (the gemcitabine-based regimen) as a new adjuvant chemotherapy for ICC radical resection (1) Appear distant organ tumor metastasis before join the group (2) Distant lymph node metastasis occurred before the group; (3)Before the survival of the tumor with more than 5 years, to rule out superficial squamous cell carcinoma and other rare ICC pathological type; (4) Prior to enrollment, any ICC radiotherapy, surgery, or other anti-tumor therapy is accepted; (5)Before the group into the whole body or liver function is not allowed to accept liver resection; (6)Before admission to receive chemotherapy, interventional treatment contraindications 2. (Folfox 6 regimen) vs the whole body (Folfox 6 regimen) vs the whole body (gemcitabine-based regimen) as a preventive chemotherapy study after radical resection of ICC patients via hepatic arterial infusion chemotherapy: (1)Intraoperative surgery after surgery to confirm the surgical margin of R1 or R2; (2)Distant lymph node metastasis occurred before the group; (3) Prior to enrollment, any ICC radiotherapy, surgery, or other anti-tumor therapy is accepted; (4)Before admission to receive chemotherapy, interventional treatment contraindications; 3. (Folfox 6 regimen) vs the whole body (Gemcitabine-based regimen) for the treatment of patients with advanced ICC who can not be surgically underwent transcatheter arterial chemoembolization (Folfox 6 regimen): (1) Prior to enrollment, any ICC radiotherapy, surgery, or other anti-tumor therapy is accepted; (2) Before admission to receive chemotherapy, interventional treatment contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICC Specimen High - throughput Gene Expression Chip; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological grading of liver biopsy;Tumor TNM classification;Blood CA-199 data;Neoadjuvant chemotherapy side effects;No postoperative tumor-free survival;Postoperative overall survival; | — |
Countries
China
Contacts
Public ContactQingguang Liu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed