Clinical trial · Interventional
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1(Intravenous combined with oral) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1: Patients testing negative for ctDNA treated using standard of care treatment
- description
- Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。
- type
- EXPERIMENTAL
- label
- Group 2: Patients with a positive ctDNA test are treated with an escalation strategy
- description
- Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。
- interventionNames
- Drug: S-1(Intravenous combined with oral)
Primary outcomes (4)
- measure
- ctDNA guided adjuvant chemotherapy versus Translational sub study
- timeFrame
- Up to 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available