OncoMatch/Clinical Trials/NCT07063888
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
Is NCT07063888 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies non-drug interventions for intrahepatic cholangiocarcinoma (icc).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: primary surgical treatment
Patients with primary surgical treatment
Cannot have received: abdominal irradiation
Had prior abdominal irradiation
Cannot have received: liver transplantation
Had prior liver transplantation
Lab requirements
Liver function
postoperative child-pugh score a5-b7
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07063888 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior abdominal irradiation, liver transplantation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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