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

Recruiting now · Phase 2

Conditions studied: Intrahepatic Cholangiocarcinoma (Icc), Adjuvant Chemoradiotherapy, Narrow Margin, Lymph Node Involvement

In brief

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.

Key facts

Study ID

NCT07063888

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

66

Starts

2025-05-16

Expected to finish

2028-05-15

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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