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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Treatment groups

66 Participants
are divided into 1 treatment group