Clinical trial · Interventional
A Randomized, Open, Prospective Clinical Research of Fluorouracil Implant to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
A Randomized, Open, Prospective Clinical Research Programs of Fluorouracil Implant (Sinofuan) to Improve Surgical Gallbladder Cancer and Bile Duct Cancer
NCT01317069CI-TRIAL-00004581unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Through clinical practice, to explore if the application of Fluorouracil implant could effectively delay the local tumor recurrence and improvement the postoperative survival time in patients with gallbladder cancer and bile duct cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil implant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluorouracil implant
- interventionNames
- Drug: Fluorouracil implant
Primary outcomes (1)
- measure
- duration of survival after operation
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- disease free survival
- timeFrame
- 1 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * The patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (Annex 2). * Aged 18 to 70 years old, male or female, body condition score generally ECOG 0~2, expected survival ≥ 3 months. * Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators: Blood: WBC count \> 3.0 × 109 / L, Platelet count\> 100 × 109 / L, Hb \> 8.0g/dl. Liver function:serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal. Renal function: creatinine less than 1.5 times the upper limit of normal. * Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test. * Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past. * Patients who can understand the circumstances of this study and signed informed consent. Exclusion Criteria: * Currently is receiving effective treatment; * Pregnancy, breast-feeding patients; * Primary brain tumors or central nervous system metastatic tumor is not controlled; * Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment. * Patients with purulent and chronic infected wounds which delayed healing. * Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease; * Patients has a history of mental illness and difficult to control; * Patients who was considered inappropriate to participate in the trials by the researchers.
References
Publications (0)
Data not yet available
No reference posted for this study.