A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
Recruiting · NCT07063888 · Interventional (participants receive a specific treatment) · Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
- Lymph node metastasis accounting for \>50% of dissected nodes
- 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 is running
1 location listed.
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences - Beijing, China