Actively Recruiting
A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-14
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a combined chemotherapy and radiotherapy treatment after liver surgery for patients with intrahepatic cholangiocarcinoma who have narrow surgical margins or lymph node involvement. This phase II trial focuses on patients who have had a hepatectomy and aims to improve disease-free survival and overall outcomes over two years. Participants will receive advanced radiation therapy techniques, either IMRT or VMAT, targeting high-risk tumor areas with a higher dose and lymphatic regions with a moderate dose across 20-25 sessions. During radiation, patients take capecitabine tablets for two cycles, followed by maintenance capecitabine for six cycles. If capecitabine is not tolerated, an alternative drug, S-1, will be used instead. Throughout the study, participants will be closely monitored for recurrence of cancer, overall survival, tumor control in the treated area, and any severe side effects. Assessments include imaging such as MRI and PET-CT scans before treatment to rule out distant cancer spread. The study tracks outcomes for up to two years to understand the treatment's impact and safety. Participants must have a good performance status and expected survival over three months to join.
CONDITIONS
Brief Title
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years and less than 80 years
- Patients who had primary surgical treatment
- Postoperative pathology confirming intrahepatic cholangiocarcinoma
- Narrow resection margin less than 1 cm or positive lymph nodes after surgery
- R0 or R1 resection status
- Postoperative Child-Pugh score between A5 and B7
- Patients with high lymph node involvement must have preoperative or pre-radiotherapy PET-CT to exclude distant metastasis
- Postoperative contrast-enhanced liver MRI to exclude intrahepatic satellite nodules
- Recovery from surgery with ECOG performance status of 0 to 2
- Estimated life expectancy greater than 3 months
You will not qualify if you...
- History of other malignancies except basal cell skin carcinoma or in situ carcinoma of the cervix
- Prior abdominal radiation therapy
- Prior liver transplantation
- Serious heart disease or kidney failure
- Moderate or severe ascites with obvious symptoms 4 months after surgery
- Time from surgery is 4 months or more
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 6 to 7 months
Participants receive adjuvant concurrent chemoradiotherapy with simultaneous integrated boost following hepatectomy, including radiotherapy in 20 to 25 fractions with concurrent capecitabine or S-1 chemotherapy, followed by maintenance capecitabine therapy.
Concurrent radiotherapy with capecitabine on days 1-14 every 21 days for 2 cycles; maintenance capecitabine on days 1-14 every 21 days for 6 cycles
Duration - Up to 24 months
Participants are monitored for disease-free survival, overall survival, local-regional control, and adverse events for up to 24 months after treatment.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
B
Bo Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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