Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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 ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai East Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.