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Efficacy and safety of intraperitoneal infusion of doxorubicin loaded microparticles combined with biliary support tube infusion in improving postoperative recurrence and metastasis of cholangiocarcinoma: a prospective clinical study

Efficacy and safety of intraperitoneal infusion of doxorubicin loaded microparticles combined with biliary support tube infusion in improving postoperative recurrence and metastasis of cholangiocarcinoma: a prospective clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042283
Enrollment
Unknown
Registered
2021-01-17
Start date
2021-01-18
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Interventions

doxorubicin loaded microparticles :Intraperitoneal perfusion combined with biliary support tube perfusion

Sponsors

Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion critetia to be allowed to participate in this study: (1) Cholangiocarcinoma was diagnosed by preoperative pathological examinarion or clincal examinarion; (2) Patients who had not received intravenous chemotherapy,radiotherapy or local administration of cholangiocarcinoma in the past four weeks: (3) ECOG score between 0-2 points; (4) The expected survival time was more than three months; (5) THe age was between 18-70 years old; (6) THe coagulation function was normal(prothrombin internaional normalized ratio INR = 60 mL/min; (8) No other serous cardiopulmonary diseases; (9) The patients agreed to be enrolled and signed the informed consent.

Exclusion criteria

Exclusion criteria: Patients with one of the following conditions cannot enter or continue the study: (1) A woman who is breatfeeding,pregnant or preparing for pregnacy; (2) Patients who are known to be allergic to test sample components or their analogues; (3) Patients with congnitive impairment or poor treatment compliance determined by researchers; (4) Parcicipants in other clinical trials within four weeks; (5) Patients with contraindications of intraperitoneal perfusion/biliary support tube perfusion; (6) Other severe,acute or chronic diseases that mat inerfere with the results of this study; (7) Patients who was not suitable for clinical trials judged by researchers.

Design outcomes

Primary

MeasureTime frame
Overall Survival, OS;progression-free survival, PFS;Local recurrence, abdominal implant metastasis or distant metastasis;

Countries

China

Contacts

Public ContactWan Chidan

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

chidanwan@163.com+86 13871289836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026