Biliary Tract Cancer
Conditions
Keywords
S-1, circulating tumor DNA (ctDNA)
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).
Interventions
DRUGS-1(Intravenous combined with oral)
Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)
Sponsors
Shanghai East Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA guided adjuvant chemotherapy versus Translational sub study | Up to 60 months | 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). |
| Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis | Up to 60 months | Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis |
| Specificity of postoperative ctDNA in monitoring recurrence and metastasis | Up to 60 months | 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 |
| Accuracy of postoperative ctDNA in monitoring recurrence and metastasis | Up to 60 months | True positive/ctDNA-positive samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months. | Overall survival of included patients |
| ctDNA clearance rate | Up to 60 months | The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy |
Countries
China
Contacts
Primary ContactJinghan Wang, M.D.
Outcome results
None listed