- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898895
COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer (CORRECT)
May 30, 2022 updated by: Ming Kuang, Sun Yat-sen University
Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ming Kuang, PhD
- Phone Number: 8576 008687755766
- Email: kuangm@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- Have other uncontrollable comorbidities;
- Infection of HIV, known syphilis requiring treatment;
- Allergic to elements of camrelizumab.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiotherapy+anti-PD-1 antibody
The total radiation dose is over 45Gy without damaging organic function.
Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed.
Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.
Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal.
If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression.
If progression is confirmed, the camrelizumab should be stopped.
|
The total radiation dose is over 45Gy without damaging organic fucntion.
Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed.
Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.
Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal.
If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression.
If progression is confirmed, the camrelizumab should be stopped.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival, OS
Time Frame: one years
|
defined as the time from the commencement of radiotherapy until death from any cause.
Patients who withdraw or are lost to follow-up or still alive will be at the date last known to be alive.
|
one years
|
Adverse events, AE
Time Frame: one years
|
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
|
one years
|
Objective response rate, ORR
Time Frame: one years
|
defined as the proportion of participants with a complete response or partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
|
one years
|
Disease control rate, DCR
Time Frame: one years
|
defined as the proportion of participants with a complete response, partial response, or stable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
|
one years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ming Kuang, PhD, First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2019
Primary Completion (Anticipated)
November 1, 2024
Study Completion (Anticipated)
November 1, 2024
Study Registration Dates
First Submitted
March 30, 2019
First Submitted That Met QC Criteria
March 30, 2019
First Posted (Actual)
April 2, 2019
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
May 30, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTC002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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