Biliary tract malignancies (including gallbladder cancer, hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, and distal bile duct cancer)
Conditions
Interventions
Control group:Radical resection of biliary tract malignancy + extended lymphadenectomy + postoperative adjuvant anti-recurrence therapy
Test group:Radical resection of biliary tract malignancy + standard(regional)lymphadenectomy+ postoperative adjuvant anti-recurrence therapy
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.?; 2.Patients diagnosed with biliary tract malignancies (including gallbladder cancer, hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, and distal bile duct cancer) based on clinical and imaging data.?; 3.Preoperative assessment confirms that curative resection of the biliary tract malignancy is feasible.?; 4.Postoperative assessment indicates suitability for standard adjuvant anti-recurrence therapy.?; 5.Adequate function of major organs meeting the following criteria:?? Neutrophil count >= 1.5 × 10^9/L Platelet count >= 90 × 10^9/L Hemoglobin >= 9 g/dL Serum albumin >= 3.5 g/dL Coagulation: International Normalized Ratio (INR) = twice the lower limit of normal* (if relevant context exists)* Total bilirubin = 60 mL/min; 6.Willing and able to understand and comply with the study protocol, voluntarily participate in the study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Participation in other clinical trials within 30 days prior to screening.?; 2.Evidence of distant metastasis confirmed by diagnostic laparoscopy or imaging studies.?; 3.History of other malignancies within 5 years or at present (excluding carcinoma in situ); or postoperative genetic testing indicating hyperprogressive disease subtype; or positive surgical margins confirmed by pathology.?; 4.Active HBV infection (HBV DNA >10^4 copies/mL or >2000 IU/mL); HCV RNA >10^3 copies/mL; other active hepatitis/cirrhosis.?; 5.Active tuberculosis (infection within 1 year prior to treatment; untreated or persistently active infection diagnosed >1 year ago).?; 6.Active or suspected autoimmune diseases (excepting hypothyroidism manageable with hormone replacement only, and skin disorders not requiring systemic therapy).?; 7.History of interstitial lung disease or non-infectious pneumonia requiring corticosteroid treatment.?; 8.Long-term systemic corticosteroid therapy (>10 mg prednisone equivalent/day) or immunosuppressants (excluding inhaled/topical corticosteroids).?; 9.Active systemic infections requiring therapeutic intervention.?; 10.HIV seropositivity.?; 11.Significant hemorrhagic tendency or active bleeding within 3 months prior to treatment.?; 12.Vulnerable populations (including individuals with psychiatric disorders, cognitive impairment, critical illness, minors, pregnant women, illiteracy, etc.).?;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year OS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory safety indicators;Surgical safety outcomes;Hospitalization expenses;Treatment-related adverse events;Overall survival,OS;Clinical benefit rate,CBR?;Recurrence free survival,RFS;Complication rate;Disease-free survival, DFS; | — |
Countries
China
Contacts
Public ContactWeifeng Tan
Tongji Hospital of Tongji University
Outcome results
None listed