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Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer (ACCORD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333927
Recruitment Status : Active, not recruiting
First Posted : April 3, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ming Kuang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Extrahepatic Cholangiocarcinoma Gallbladder Cancer Drug: Chemotherapy Other: Observation Procedure: Immunotherapy Radiation: Radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Treatment
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).
Drug: Chemotherapy
Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).

Procedure: Immunotherapy
Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.

Radiation: Radiotherapy
45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.

Placebo Comparator: Observation
Patients in observation group will not receive any anti-cancer therapy.
Other: Observation
Patients in observation group will not receive any anti-cancer therapy.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: two years ]
    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 :
  1. Recurrence-free Survival [ Time Frame: two years ]
    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.

  2. Adverse Events [ Time Frame: two years ]
    adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-70 years;
  2. Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
  3. Pathology indicates R0 with T2-4 or N1; or R1;
  4. ECOG PS 0-1;
  5. 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;
  6. At least 6 months of life expectancy.

Exclusion Criteria:

  1. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
  2. Received previous anti-cancer therapies;
  3. With purulent, infected or delayed healed wounds;
  4. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
  5. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
  6. Have taken aspirin (>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
  7. Uncontrollable hypertension, systolic pressure>140mmHg or diastolic pressure>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
  8. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc>500ms upon screening;
  9. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
  10. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
  11. Have a known history of prior invasive malignancies within 5 years before enrolment;
  12. Have other uncontrollable comorbidities;
  13. Infection of HIV, known syphilis requiring treatment;
  14. Allergic to chemotherapeutics.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333927


Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Ming Kuang, PhD First Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Ming Kuang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04333927    
Other Study ID Numbers: BTC001
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Biliary Tract Neoplasms
Gallbladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma
Carcinoma
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases