Actively Recruiting
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-07-14
66
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 > 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 with either lymph node metastasis >50% of dissected nodes or lymph node metastasis involving the paracardial region or below the renal vein level must undergo preoperative or pre-radiotherapy PET-CT to exclude distant or extended lymph node metastasis
- 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
You will not qualify if you...
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Prior abdominal irradiation
- Prior liver transplantation
- Serious myocardial disease or renal failure
- Moderate or severe ascites with obvious symptoms 4 months after surgery
- Duration from surgery ≥ 4 months
AI-Screening
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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
CONTACT
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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