Postoperative concurrent chemoradiotherapy with simultaneous integrated boost for intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.