Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

Not Applicable

Not yet recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: S-1(Intravenous combined with oral)

• Registration Number: NCT06171321
• Lead Sponsor: Shanghai East Hospital

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 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.

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 (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-14
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Primary Completion: 2025-11-15
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Patients with a positive ctDNA test are treated with an escalation strategy	S-1(Intravenous combined with oral)	Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。

Primary Outcome Measures

Name	Time	Method
Specificity of postoperative ctDNA in monitoring recurrence and metastasis	Up to 60 months	Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
ctDNA guided adjuvant chemotherapy versus Translational sub study	Up to 60 months	To demonstrate the superiority of an escalation strategy of ctDNA-guided adjuvant chemotherapy over standard-of-care treatment, 2-year disease-free survival (DFS) was measured as 2-year Disease-Free Survival (DFS) in high-risk stage II-III BTC patients with no evidence of minimal residual disease (ctDNA-negative).
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis	Up to 60 months	True positive/ctDNA-positive samples
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis	Up to 60 months	Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.	Overall survival of included patients
ctDNA clearance rate	Up to 60 months	The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy

Trial Locations

Locations (1)

East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, China