Postoperative concurrent chemoradiotherapy with simultaneous integrated boost for 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
This treatment tests whether adding postoperative concurrent chemoradiotherapy with a simultaneous integrated boost plus oral capecitabine can reduce recurrence in adults after liver surgery for intrahepatic cholangiocarcinoma with narrow margins or positive lymph nodes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07063888 on ClinicalTrials.gov |
What this trial studies
This single-arm phase II trial gives IMRT or VMAT radiation with a simultaneous integrated boost to the tumor bed or involved nodes (55–60 Gy) and a lower dose to lymphatic regions (40–45 Gy) over 20–25 fractions after hepatectomy. Patients receive concurrent capecitabine during radiotherapy and then maintenance capecitabine for up to six cycles, with S-1 as an alternative if capecitabine is not tolerated. Key eligibility includes R0/R1 resection for intrahepatic cholangiocarcinoma with a resection margin <1 cm or positive lymph nodes, adequate liver function, and no distant metastasis on required imaging. The primary endpoint is 2-year recurrence-free survival, with secondary endpoints including 2-year overall survival and local-regional control rates.
Who should consider this trial
Good fit: Adults 18–80 years with pathologically confirmed intrahepatic cholangiocarcinoma who had R0/R1 hepatectomy with a margin <1 cm or positive lymph nodes, adequate liver function (Child‑Pugh A5–B7), ECOG 0–2, and no distant metastasis on required imaging are ideal candidates.
Not a fit: Patients with distant metastases, extensive nodal disease beyond the planned radiation region, poor liver function, ECOG >2, or who cannot tolerate capecitabine are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower post‑surgical recurrence and improve 2-year recurrence-free and overall survival for high-risk intrahepatic cholangiocarcinoma patients.
How similar studies have performed: Prospective randomized data are limited for adjuvant chemoradiotherapy in intrahepatic cholangiocarcinoma, with mainly retrospective series suggesting possible benefit but no definitive consensus.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Bo Chen, MD
- Email: chenboo@outlook.com
- Phone: 00861324000876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.