Back to resultsAdjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer (ACCORD)
Primary Purpose
Biliary Tract Cancer, Extrahepatic Cholangiocarcinoma, Gallbladder Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Observation
Immunotherapy
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
Eligibility Criteria
Inclusion Criteria:
- Age: 18-70 years;
- Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
- Pathology indicates R0 with T2-4 or N1; or R1;
- ECOG PS 0-1;
- Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;
- At least 6 months of life expectancy.
Exclusion Criteria:
- Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
- Received previous anti-cancer therapies;
- With purulent, infected or delayed healed wounds;
- 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;
- Have other uncontrollable comorbidities;
- Infection of HIV, known syphilis requiring treatment;
- Allergic to chemotherapeutics.
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Observation
Arm Description
Patients in treatment group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed).
Patients in observation group will not receive any anti-cancer therapy.
Outcomes
Primary Outcome Measures
Overall Survival
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Secondary Outcome Measures
Recurrence-free Survival
defined as the time from randomization until disease recurrence or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence-free. Patients not having an event will be censored at the date last seen alive.
Adverse Events
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04333927
Brief Title
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer
Acronym
ACCORD
Official Title
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer: a Phase II, Multicenter, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 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 multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.
Detailed Description
The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer, Extrahepatic Cholangiocarcinoma, Gallbladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients in treatment group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed).
Arm Title
Observation
Arm Type
Placebo Comparator
Arm Description
Patients in observation group will not receive any anti-cancer therapy.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Patients in observation group will not receive any anti-cancer therapy.
Intervention Type
Procedure
Intervention Name(s)
Immunotherapy
Intervention Description
Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.
Primary Outcome Measure Information:
Title
Overall Survival
Description
defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Recurrence-free Survival
Description
defined as the time from randomization until disease recurrence or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and recurrence-free. Patients not having an event will be censored at the date last seen alive.
Time Frame
two years
Title
Adverse Events
Description
adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-70 years;
Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
Pathology indicates R0 with T2-4 or N1; or R1;
ECOG PS 0-1;
Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;
At least 6 months of life expectancy.
Exclusion Criteria:
Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
Received previous anti-cancer therapies;
With purulent, infected or delayed healed wounds;
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;
Have other uncontrollable comorbidities;
Infection of HIV, known syphilis requiring treatment;
Allergic to chemotherapeutics.
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
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer
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