An observational study in Lymph Node Metastasis, Neurovascular Invasion and Pathology Showed R1 Resection, sponsored by Hengchao Yu. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Hengchao Yu · Observational
The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.
This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection. The study will enroll patients with ECC who have not received prior systemic therapy. The primary endpoint is the 2-year recurrence-free survival rate (2y-RFS), with a planned enrollment of approximately 65 subjects.
After providing full informed consent, eligible patients will receive treatment with tislelizumab injection combined with capecitabine and radiotherapy. Each study treatment cycle is 3 weeks, and treatment will continue until the criteria for terminating study treatment are met.
Treatment regimen for the treatment group:
248 studies on the registry are indexed under Lymphatic Metastasis; 92 are open to participants now.
This study's planned enrollment of 10 is below the median of 248 across 116 observational studies indexed under Lymphatic Metastasis.
Browse Lymphatic Metastasis studies →This is the only study on the registry with Hengchao Yu as lead sponsor.
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Patients With High-risk resectable Extrahepatic Cholangiocarcinoma
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is a single-arm, prospective clinical study designed to evaluate the efficacy and safety of tislelizumab injection combined with capecitabine and radiotherapy as first-line adjuvant therapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma (ECC) resection.
Combination Product: Adjuvant Immunotherapy Combined With ChemoRadiation for Patients With High-risk resectable Extrahepatic Cholangiocarcinoma(AICRC)
The purpose of this prospective, observational study is to investigate whether adjuvant chemoradiotherapy combined with immunotherapy for high-risk recurrence populations after extrahepatic cholangiocarcinoma resection can improve patients' recurrence-free survival. The primary study endpoint of this prospective study is the 2-year recurrence-free survival.
2-year recurrence-free survival rate
The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the recurrence-free survival status of patients will be observed at 2 years.
Time frame: 2 Year
2-year overall survival rate
The target population is enrolled and receives postoperative adjuvant therapy according to the study protocol, the overall survival status of patients will be observed at 2 years.
Time frame: 2 Year
Incidence of adverse events
Time frame: 2 Year
Completion rate of treatment
Time frame: 2 Year
Plan to share: Yes — The survival data of the Patients With High-risk resectable Extrahepatic Cholangiocarcinoma after treatment
Supporting information: Study protocol
Time frame: 2 Year
Access criteria: All medical workers
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for May 2026, 14 months after the start.
Of 49 non-industry observational studies under Lymphatic Metastasis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 14 months is below that.
Counting every sponsor, half of 49 studies reached it within 38 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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