Status:
TERMINATED
A Study of Tislelizumab Combined With Radiotherapy as the Second-line Treatment of Advanced Biliary Malignant Tumors
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Biliary tract cancer (BTC) accounts for 4% of the malignant tumors of the digestive system, and the incidence has increased significantly in recent years. For advanced malignant tumors of the biliary ...
Detailed Description
Patient recruitment Research and discussion by the MDT team of the Department of Hepatobiliary Surgery of our center: Choose pathologically confirmed malignant tumors of the biliary tract that are ino...
Eligibility Criteria
Inclusion
- Pathological diagnosis of Advanced biliary malignancy
- The expected survival period is ≥3 months
- Patients with non-extensive metastases
- Except for the lesions to be radiotherapy, there is at least one measurable lesion
- tumor lesions are suitable for radiotherapy
- Have previously received platinum, gemcitabine or 5-FU drugs as first-line treatment, but have not used PD-1/PD-L1 monoclonal antibody treatment
- In the 7 days before enrollment, the Child Pugh score of liver function is 7 or less
Exclusion
- Patients with other malignant tumors
- Participated in other drug clinical trials within four weeks
- Clinical diagnosis of severe biliary obstruction or digestive tract obstruction in the past month
- Unstable angina pectoris
- Immunodeficiency
- Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia
- Patients who need to use corticosteroids
- Serious chronic autoimmune diseases
- Ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases
- Inflammatory and chronic diarrheal diseases such as irritable bowel syndrome;
- Sarcoidosis or tuberculosis
- Patients with hypersensitivity to human or murine monoclonal antibodies
- Pregnant and lactating women
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04866836
Start Date
October 1 2020
End Date
October 1 2022
Last Update
March 21 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000