Status:
NOT_YET_RECRUITING
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma
Lead Sponsor:
Shanghai East Hospital
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDN...
Detailed Description
The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RF...
Eligibility Criteria
Inclusion
- 1\) Patients with pathologically confirmed BTCs according to the UICC/AJCC TNM staging system (8th edition 2017) for stage II-III tumours. Patients eligible for radical resection of BTCs. No synchronous or metastatic malignant tumour found in other organs other than the primary tumor.
- 2\) Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 2.
- 3）With expected survival of more than 12 months. 4) Radical operation performed.
Exclusion
- 1\) Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
- 2\) Blood transfusion performed during operation or within 2 weeks before operation.
- 3\) Have a history of other malignant tumors within 5 years.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06171321
Start Date
December 1 2023
End Date
April 1 2026
Last Update
December 14 2023
Active Locations (1)
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1
East Hospital, Tongji University School of Medicine
Shanghai, China