Biliary Tract Cancer
Conditions
Interventions
Surgery + IPHP group:intraperitoneal hyperthermic perfusion chemotherapy , Radical resection surgery for malignant biliary tumors
Surgery group:Radical resection surgery for malignant biliary tumors
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Voluntary participation with a signed consent form; 2 Patients with biliary tract malignancy diagnosed preoperatively by puncture pathology histology or cytology; 3 Age 18-75 years old, regardless of gender; 4 Eastern Cooperative Oncology Group ECOG score 0-1; 5 AJCC 8th edition stage III and IV patients with surgical evaluation of junction resectable and locally advanced gallbladder and bile duct cancers. and cholangiocarcinoma; 6 Patients who are autonomous, understand and voluntarily sign the written informed consent and are able to complete the follow-up programme; 7 Female patients of gestational age should be excluded from pregnancy; 8 Signed written informed consent prior to screening.
Exclusion criteria
Exclusion criteria: 1 Patients who do not wish to undergo chemotherapy or surgery; 2 Patients who have developed extensive liver metastases, peritoneal metastases and extensive abdominal lymph nodes or metastases to other organs; 3 Patients who have been systematically assessed as intolerant of surgery, or patients who cannot be resected by surgery; 4 With other tumours; 5 Patients with previous treatment such as chemotherapy, radiotherapy or intervention; 6 Pregnant or breastfeeding women, men and women of childbearing age who are unwilling or unable to use effective contraception; 7 History of other malignant tumours in the last 5 years; 8 With active bleeding or abnormal coagulation function (PT > 16s, APTT > 43s, INR > 1.5 x ULN), with bleeding tendency or under thrombolytic, anticoagulant or antiplatelet therapy; 9 Central nervous system metastasis; 10 A history of gastrointestinal bleeding within the previous 6 months or a definite tendency to gastrointestinal bleeding, e.g., a known locally active ulcerative lesions, fecal occult blood (+ +) or more may not be enrolled; if fecal occult blood (+) persists, a gastroscopy should be performed;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS;Relative risk ratio for the occurrence of peritoneal implant metastases; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;Adverse Events;Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactJiong Lu
West China Hospital of Sichuan University
Outcome results
None listed