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

NCT ID: NCT07063888

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2028-05-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Group Type: EXPERIMENTAL

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Intervention Type: 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.

Interventions

Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

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.

Intervention Type: RADIATION

Eligibility Criteria

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

1. Lymph node metastasis accounting for >50% of dissected nodes

2. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

BO CHEN

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Bo Chen, MD

Role: CONTACT

chenboo@outlook.com

00861324000876

Facility Contacts

Bo Chen, MD

Role: primary

chenboo@outlook.com

00861324000876

Other Identifiers

NCC5322

Identifier Type: -

Identifier Source: org_study_id