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

NCT07063888 | Recruiting Phase 2 DMC

• 1 other identifier: NCC5322
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrahepatic Cholangiocarcinoma (Icc); Adjuvant Chemoradiotherapy; Narrow Margin; Lymph Node Involvement

Outcome Measures

Primary Outcomes (1)

• Two-year Disease-free Survival

  Disease-free survival was calculated from the date of surgical resection to the date of the first recurrence or death

  up to 24 months

Secondary Outcomes (3)

• Two-year Overall Survival

  up to 24 months

• Local-Regional Control Rate

  up to 24 months

• Incidence of Grade 3 or Higher Adverse Events

  up to 24 months

Study Arms (1)

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

EXPERIMENTAL

Radiation: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Interventions

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.

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Bo Chen, MD

CONTACT

00861324000876; chenboo@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

CN (1)