Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

Tongji University

Status: Not yet enrolling

Conditions: Biliary Tract Cancer

Treatments: Drug: S-1(Intravenous combined with oral)

Study type: Interventional

Funder types: Other

Identifiers

NCT06171321

[2023] R&R No. (107)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

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

No Intervention group

Description:

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 group

Description:

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

Treatment:

Drug: S-1(Intravenous combined with oral)