Clinical trial NCT06171321: Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma
Official title: Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biliary Tract Cancer
Keywords: S-1
circulating tumor DNA (ctDNA)
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: ctDNA guided adjuvant chemotherapy versus Translational sub study
timeFrame: Up to 60 months
measure: Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
timeFrame: Up to 60 months
measure: Specificity of postoperative ctDNA in monitoring recurrence and metastasis
timeFrame: Up to 60 months
measure: Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
timeFrame: Up to 60 months
Secondary outcomes:
measure: overall survival (OS)
timeFrame: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
measure: ctDNA clearance rate
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: East Hospital, Tongji University School of Medicine
Study officials:
References: