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Search / Trial NCT07063888

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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jul 11, 2025

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have had surgery to remove intrahepatic cholangiocarcinoma, a type of liver cancer. The trial is testing whether giving radiation therapy together with chemotherapy after surgery can help prevent the cancer from coming back, especially in patients whose surgery left a very small margin around the tumor or who have cancer in nearby lymph nodes. The radiation targets the area where the tumor was removed and the nearby lymph nodes, while chemotherapy is given by mouth during and after radiation to help kill any remaining cancer cells.

To join this study, patients must be adults under 80 years old who recently had surgery for this type of liver cancer and have either a narrow margin (less than 1 cm) around the tumor or cancer found in lymph nodes. They must be well enough to receive treatment and have no distant spread of cancer outside the liver area. During the trial, participants will receive precise radiation therapy along with a chemotherapy pill called capecitabine for about two months, followed by additional chemotherapy for several more months. If capecitabine is not tolerated, another similar medication can be used. The main goal is to see how many patients remain cancer-free two years after treatment, while also monitoring overall survival and side effects. This study is currently recruiting patients who meet these criteria.

Gender

ALL

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

About Cancer Institute And Hospital, Chinese Academy Of Medical Sciences

The Cancer Institute and Hospital of the Chinese Academy of Medical Sciences is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and comprehensive patient services. As a prominent institution in oncology, it focuses on integrating cutting-edge research with clinical practice, fostering collaborations that enhance the understanding and treatment of various cancer types. The institute is committed to improving patient outcomes by exploring novel therapies, optimizing treatment protocols, and contributing to the global fight against cancer through rigorous scientific investigation and evidence-based practices.

Locations

Beijing, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported