Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

Biliary Tract Cancer Clinical Trial

Official title:

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171321
• Other study ID #: [2023] R&R No. (107)
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: November 2023
• Source: Shanghai East Hospital
• Contact: Jinghan Wang, M.D.
• Phone: +86-13795362134
• Email: wangjinghan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: April 1, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• S-1(Intravenous combined with oral)
Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)

Locations

Country	Name	City	State
China	East Hospital, Tongji University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA guided adjuvant chemotherapy versus Translational sub study	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).	Up to 60 months
Primary	Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis	Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis	Up to 60 months
Primary	Specificity of postoperative ctDNA in monitoring recurrence and metastasis	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	Up to 60 months
Primary	Accuracy of postoperative ctDNA in monitoring recurrence and metastasis	True positive/ctDNA-positive samples	Up to 60 months
Secondary	overall survival (OS)	Overall survival of included patients	From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
Secondary	ctDNA clearance rate	The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy	Up to 60 months