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NCT Number: NCT07063888

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

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.

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Key information

Conditions

Intrahepatic Cholangiocarcinoma (Icc) Adenocarcinoma Adjuvant Chemoradiotherapy Carcinoma Cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension Lymph Node Involvement Narrow Margin Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Bo Chen, MD

CONTACT

[email protected]

00861324000876

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Radiation

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.

Primary outcomes

  1. Two-year Disease-free Survival

    Time frame: 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 outcomes

  1. Two-year Overall Survival

    Time frame: up to 24 months

    Overall survival was calculated from the date of surgical resection to the date of death from any cause

  2. Local-Regional Control Rate

    Time frame: up to 24 months

    Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control.

  3. Incidence of Grade 3 or Higher Adverse Events

    Time frame: up to 24 months

    Adverse events was evaluated during received protocol therapy according to CTCAE 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Chen, MD

CONTACT

[email protected]

00861324000876

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Prospective Phase II Study of Adjuvant Concurrent Chemoradiotherapy With Simultaneous Integrated Boost Following Hepatectomy for Intrahepatic Cholangiocarcinoma With Narrow Margin or Nodal Involvement

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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