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COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable inTrahepatic Cholangiocarcinoma (CORRECT)

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ClinicalTrials.gov Identifier: NCT03898895
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ming Kuang, Sun Yat-sen University

Brief Summary:
The study is a multicenter phase II randomized trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody and chemotherapy (gemcitabine+cisplatin) in unresectable intrahepatic cholangiocarcinoma patients.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Radiotherapy Immunotherapy Combination Product: SBRT+anti-PD-1 Drug: Gemcitabine+cisplatin Phase 2

Detailed Description:
The trial will recruit 184 patients, and they will be randomized (1:1) to two groups (radiotherapy+anti-PD-1 group, gemcitabine+cisplatin group). Patients in radiotherapy+anti-PD-1 group will receive stereotactic body radiotherapy (SBRT) 30-50Gy for 3-5 fractions during 2 weeks. Camrelizumab 200mg intravenously every 2 weeks will be initiated within 7 days after the final SBRT fraction. Patients in chemotherapy group will receive cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Intrahepatic Cholangiocarcinoma
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Experimental: SBRT+anti-PD-1
SBRT 30-50Gy for 3-5 fractions during 2 weeks. Camrelizumab 200mg intravenously every 2 weeks will be initiated within 7 days after the final SBRT fraction. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study 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 whether the progression is true or not. If it is true, the camrelizumab should be stopped.
Combination Product: SBRT+anti-PD-1
SBRT 30-50Gy for 3-5 fractions during 2 weeks. Camrelizumab 200mg intravenously every 2 weeks will be initiated within 7 days after the final SBRT fraction. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study 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 whether the progression is true or not. If it is true, the camrelizumab should be stopped.
Other Name: RI

Active Comparator: Gemcitabine+cisplatin
Cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.
Drug: Gemcitabine+cisplatin
Cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.
Other Name: GP




Primary Outcome Measures :
  1. Progression-free survival, PFS [ Time Frame: two years ]
    defined as the time from randomization 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 last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive and progression free.


Secondary Outcome Measures :
  1. Overall survival, OS [ 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.

  2. Adverse events, AE [ Time Frame: two years ]
    adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).

  3. Tumor response [ Time Frame: two years ]
    measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-75 years;
  2. Primary unresectable ICC without previous treatment;
  3. Eligible for radiotherapy, chemotherapy and immunotherapy after evaluation of specialized experts;
  4. At least one measurable lesion based on RECIST 1.1 criteria;
  5. Child-Pugh A class;
  6. ECOG PS 0-1;
  7. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT、AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
  8. At least 12 weeks of life expectancy.

Exclusion Criteria:

  1. Have active autoimmune diseases that have required systemic treatment;
  2. Have a known history of prior invasive malignancies;
  3. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
  4. Have uncontrollable comorbidities;
  5. Infection of HIV.

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): NCT03898895


Contacts
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Contact: Ming Kuang, PhD 008687755766 ext 8576 kuangm@mail.sysu.edu.cn

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: NCT03898895     History of Changes
Other Study ID Numbers: ICC001
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Gemcitabine
Antibodies
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs