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Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

NCT ID: NCT06171321

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2026-04-01

Brief Summary

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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

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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).

Conditions

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Biliary Tract Cancer

Keywords

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S-1 circulating tumor DNA (ctDNA)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type EXPERIMENTAL

S-1(Intravenous combined with oral)

Intervention Type DRUG

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

Interventions

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S-1(Intravenous combined with oral)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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East Hospital, Tongji University School of Medicine

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Jinghan Wang, M.D.

Role: CONTACT

Phone: +86-13795362134

Email: [email protected]

Other Identifiers

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[2023] R&R No. (107)

Identifier Type: -

Identifier Source: org_study_id