Back to resultsCOmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer (CORRECT)
Primary Purpose
Biliary Tract Cancer, Radiotherapy, Immunotherapy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy+anti-PD-1 antibody
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
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;
- 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.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy+anti-PD-1 antibody
Arm Description
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.
Outcomes
Primary Outcome Measures
Progression-free survival, PFS
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.
Secondary Outcome Measures
Overall survival, OS
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.
Adverse events, AE
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Objective response rate, ORR
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.
Disease control rate, DCR
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03898895
Brief Title
COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer
Acronym
CORRECT
Official Title
Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer, Radiotherapy, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy+anti-PD-1 antibody
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Radiotherapy+anti-PD-1 antibody
Other Intervention Name(s)
RT/IO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival, PFS
Description
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.
Time Frame
one years
Secondary Outcome Measure Information:
Title
Overall survival, OS
Description
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.
Time Frame
one years
Title
Adverse events, AE
Description
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time Frame
one years
Title
Objective response rate, ORR
Description
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.
Time Frame
one years
Title
Disease control rate, DCR
Description
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.
Time Frame
one years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Kuang, PhD
Phone
008687755766
Ext
8576
Email
kuangm@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Kuang, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Kuang, Ph.D.
Phone
008687755766
Ext
8576
Email
kuangm@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer
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