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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)
East Hospital, Tongji University School of Medicine
Shanghai, China
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).
Time frame: 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
Time frame: 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
Time frame: Up to 60 months
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
True positive/ctDNA-positive samples
Time frame: Up to 60 months
overall survival (OS)
Overall survival of included patients
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months.
ctDNA clearance rate
The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy
Time frame: Up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.