Clinical trial · Interventional
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adjuvant Chemoradiotherapy | — | UNRESOLVED | — |
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Lymph Node Involvement | — | UNRESOLVED | — |
| Narrow Margin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
- interventionNames
- Radiation: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
Primary outcomes (1)
- measure
- Two-year Disease-free Survival
- timeFrame
- up to 24 months
- description
- Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death
Secondary outcomes (3)
- measure
- Two-year Overall Survival
- timeFrame
- up to 24 months
- description
- Overall survival was calculated from the date of surgical resection to the date of death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 1. Lymph node metastasis accounting for \>50% of dissected nodes 2. Lymph node metastasis involving the paracardial region or below the renal vein level * 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: * History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix * Had prior abdominal irradiation * Had prior liver transplantation * Had serious myocardial disease or renal failure * Had moderate or severe ascites with obvious symptoms 4 months after surgery * Duration from surgery ≥ 4 months
References
Publications (0)
Data not yet available