Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

NCT06171321 | Not Yet Recruiting DMC

• 1 other identifier: [2023] R&R No. (107)
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Keywords

S-1; circulating tumor DNA (ctDNA)

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Accuracy of postoperative ctDNA in monitoring recurrence and metastasis

  True positive/ctDNA-positive samples

  Up to 60 months

Secondary Outcomes (2)

• overall survival (OS)

  From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.

• ctDNA clearance rate

  Up to 60 months

Study Arms (2)

Group 1: Patients testing negative for ctDNA treated using standard of care treatment

NO INTERVENTION

Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。

Group 2: Patients with a positive ctDNA test are treated with an escalation strategy

EXPERIMENTAL

Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。

Drug: S-1(Intravenous combined with oral)

Interventions

S-1(Intravenous combined with oral) DRUG

Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)

Group 2: Patients with a positive ctDNA test are treated with an escalation strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• \) Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 2.
• ）With expected survival of more than 12 months. 4) Radical operation performed.

You may not qualify if:

• \) Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
• \) Blood transfusion performed during operation or within 2 weeks before operation.
• \) Have a history of other malignant tumors within 5 years.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

East Hospital, Tongji University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Jinghan Wang, M.D.

CONTACT

+86-13795362134; wangjinghan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 14, 2023
• Study Start: December 1, 2023
• Primary Completion: November 15, 2025
• Study Completion: April 1, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-11

Locations

CN (1)