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This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy for intrahepatic cholangiocarcinoma with narrow margin (<1cm) or nodal involvement. Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg/m² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg/m² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. The primary endpoint is 2-year recurrence-free survival. The secondary endpoints are 2-year overall survival, local-regional control rate and incidence of grade 3 or higher adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost | Radiation | Eligibility patients will receive IMRT or VMAT. The prescription dose to high-risk area of tumor bed or positive lymph node was planned at 55-60Gy and the prescription dose to lymphatic drainage regions was planned at 40-45Gy in 20-25 fractions. During radiotherapy, patients will concurrently receive capecitabine (1600 mg/m² on days 1-14, every 21 days for 2 cycles). After radiotherapy, maintenance therapy with capecitabine will continue (2000 mg/m² on days 1-14, every 21 days for 6 cycles). For patients who cannot tolerate capecitabine, S-1 will be used as an alternative. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-year Disease-free Survival | Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Two-year Overall Survival | Overall survival was calculated from the date of surgical resection to the date of death from any cause | up to 24 months |
| Local-Regional Control Rate | Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control. |
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Inclusion Criteria:
Age > 18 years, < 80 years
Patients with primary surgical treatment
Postoperative pathology confirmed intrahepatic cholangiocarcinoma
Postoperative pathology showing narrow resection margin (<1cm) or positive lymph nodes
R0/R1 resection
Postoperative Child-Pugh score A5-B7
Patients meeting either of the following conditions must undergo preoperative or pre-radiotherapy PET-CT to exclude distant metastasis or lymph node metastasis beyond the region from the lower esophagus to the aortic bifurcation
Postoperative contrast-enhanced liver MRI to exclude Intrahepatic satellite nodules
Recovery from surgery with Eastern Cooperative Oncology Group performance status score of 0-2
Estimated life expectancy >3 months
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Chen, MD | Contact | 00861324000876 | chenboo@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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|
| up to 24 months |
| Incidence of Grade 3 or Higher Adverse Events | Adverse events was evaluated during received protocol therapy according to CTCAE 5.0 | up to 24 months |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| C562580 | Cirrhosis, Familial, with Pulmonary Hypertension |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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