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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

Lymph Node Involvement

Adjuvant Chemoradiotherapy

Narrow Margin

Intrahepatic Cholangiocarcinoma (Icc)

Treatments

Radiation: Adjuvant Concurrent Chemoradiotherapy with Simultaneous Integrated Boost

Study type

Interventional

Funder types

Other

Identifiers

NCT07063888

NCC5322

Details and patient eligibility

About

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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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