An interventional study of S-1(Intravenous combined with oral) in Biliary Tract Cancer, sponsored by Shanghai East Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Shanghai East Hospital · Not applicable, Interventional, and Treatment
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).
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 94 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
3）With expected survival of more than 12 months. 4) Radical operation performed.
Exclusion Criteria:
Patients with positive surgical margins and residual lesions after biliary tract tumor surgery.
Postoperative ctDNA-negative patients receive oral Teysuno (S-1) for adjuvant therapy。
Postoperative ctDNA-positive patients receive intravenous combined oral Teysuno (S-1) for adjuvant therapy。
Drug: S-1(Intravenous combined with oral)
Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)
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 study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Shanghai East Hospital