NCT07063888RecruitingPhase 2
A Prospective Phase II Study of Postoperative Concurrent Chemoradiotherapy in Patients With Intrahepatic Cholangiocarcinoma
A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement
Source: ClinicalTrials.gov · Last updated 14 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 3 Jul 2025
- Start date
- 16 May 2025
- Primary completion date
- 15 May 2028
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07063888
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 16 May 2025 to the primary completion date, 15 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had moderate or severe ascites with obvious symptoms 4 months after surgery
- Duration from surgery ≥ 4 months
Other illness
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had serious myocardial disease or renal failure
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.