A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Bo Chen, MD
chenboo@outlook.com
00861324000876
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2028-05-15
Participants
Target number of participants: 66
Treatments
Experimental: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov