A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma

Not Applicable

Recruiting

• Conditions: Intrahepatic Cholangiocarcinoma (Icc); Adjuvant Chemoradiotherapy; Narrow Margin; Lymph Node Involvement

• Registration Number: NCT07063888
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-16
• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2028-05-15
• Study Completion: 2028-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Two-year Disease-free Survival	up to 24 months	Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death

Secondary Outcome Measures

Name	Time	Method
Two-year Overall Survival	up to 24 months	Overall survival was calculated from the date of surgical resection to the date of death from any cause
Local-Regional Control Rate	up to 24 months	Patients with stable disease \[SD\], partial response \[PR\] or complete response\[CR\] were recorded as local control.
Incidence of Grade 3 or Higher Adverse Events	up to 24 months	Adverse events was evaluated during received protocol therapy according to CTCAE 5.0

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China