Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer

Sun Yat-sen University1 site in 1 country36 target enrollmentDecember 10, 2019

ConditionsBiliary Tract Cancer Radiotherapy Immunotherapy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Biliary Tract Cancer
Sponsor: Sun Yat-sen University
Enrollment: 36
Locations: 1
Primary Endpoint: Progression-free survival, PFS
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a single-arm, phase II trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody in unresectable biliary tract cancer patients.

Detailed Description

The trial will recruit 36 patients, and they will undergo radiotherapy plus anti-PD-1 antibody. Patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.

Registry

clinicaltrials.gov

Start Date

December 10, 2019

End Date

November 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Ming Kuang

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Aged between 18 and 75 years old;
•Histopathologically confirmed unresectable primary or initial postoperative recurrent BTC without distant metastasis;
•No previous radiotherapy or systemic therapy;
•Adequate volume of the uninvolved liver (larger than 700 mL);
•At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors 1.1 criteria;
•Eastern Cooperative Oncology Group performance status score of 0 or 1;
•Adequate hematologic (absolute neutrophil count ≥ 1.5x109/L, hemoglobin concentration ≥ 90g/L, platelet count ≥ 100 x109/L), hepatic (albumin ≥ 28 g/L, total bilirubin \< 1.5 times the upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase \< 5×ULN) and renal function (serum creatine \< 1.5×ULN, creatinine clearance rate ≥ 45ml/min);
•Life expectancy of at least 12 weeks.

Exclusion Criteria

•Have acute or chronic active hepatitis B or C, HBV-DNA\>2000IU/ml or 104 copy/ml; HCV-RNA\>103 copy/ml; both HBsAg and HCV antibody are positive. If the related results become lower than above standards after anti-viral treatment, the patients are qualified for enrolment;
•Have metastasis in extrahepatic distant organs including lung, central nervous system, bone and etc. Or extrahepatic lymph node metastasis beyond abdomen;
•Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
•Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
•Have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
•Uncontrollable hypertension, systolic pressure\>140mmHg or diastolic pressure\>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
•Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc\>500ms upon screening;
•Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
•Active tuberculosis, having antituberculosis therapy at present or within 1 year;
•Have a known history of prior invasive malignancies within 5 years before enrolment;

Outcomes

Primary Outcomes

Progression-free survival, PFS

Time Frame: one years

defined as the time from the commencement of radiotherapy until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date of the last adequate tumor assessment. Patients not having an event will be censored at the date of the last adequate tumor assessment. If patients don't have baseline tumor assessments, they will be censored at the date of the first treatment.