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Trial record 9 of 34 for:    Han weidong

Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs

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: NCT03311789
Recruitment Status : Unknown
Verified October 2017 by Han weidong, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:

This is a single-arm, phase I/II trial in biliary tract cancer (BTC) patients. The purpose of this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with gemcitabine/cisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs.

The primary objective: 6-month progression free survival (PFS). The second objectives: objective clinical response(according to RECIST version 1.1), safety, symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21), overall survival. The exploratory objectives: assessment of immunological response (cytokines, lymphocyte phenotype, immunoglobulins), and evaluation of pathological, immunological and clinical predictive factors for response/toxicity.


Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: PD-1 inhibitor + Gemcitabine + Cisplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Enrolled patients will be treated with PD-1 inhibitor in combination with gemcitabine/cisplatin chemotherapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: PD-1 inhibitor + Gemcitabine+Cisplatin
Patients will be enrolled in the experimental arm and will receive Gemcitabine on day 1 and 5 (1000mg/m2 ) +Cisplatin on day 1(75mg/m2)+ PD-1 inhibitor on day 3 (Nivolumab 3mg/kg, or SHR-1210 200mg) every 3 weeks. If there is continued benefit after 6 months, PD-1 inhibitor will be administered as maintenance treatment until tumor progression or death.
Drug: PD-1 inhibitor + Gemcitabine + Cisplatin
Gemcitabine: 1000mg/m2 on day 1 and 5 every 3 weeks. Cisplatin: 75mg/m2 on day 1 every 3 weeks. PD-1 inhibitor: Nivolumab 3mg/kg, or SHR-1210 200mg.
Other Name: Nivolumab or SHR-1210




Primary Outcome Measures :
  1. The percentage of patients alive and without progression at 6 months [ Time Frame: 6 months ]
    The primary objective of this trial is the progression free survival (PFS) at 6 months in patients with advanced unresectable or metastatic BTCs treated with PD-1 inhibitor in combination with gemcitabine plus cisplatin. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (irRECIST) definition


Secondary Outcome Measures :
  1. The percentage of patients that respond to combination treatment [ Time Frame: Enrolled patients will be followed until death, withdrawal from study, or until 2 years. ]
    Overall response rate is defined as the sum of partial responses and complete responses. Partial and complete response will be defined as per irRECIST criteria.

  2. Median overall survival time [ Time Frame: Patients will be followed until death, withdrawal from study, or until 2 years. ]
    The median overall survival (OS) time is defined as the time from enrollment to death.

  3. List of adverse event frequency and grade [ Time Frame: Up to 120 days after last administration of PD-1 inhibitor ]
    To evaluate the safety of PD-1 inhibitor in combination with standard chemotherapy in patients with advanced BTCs according to CTCAE 4.0.



Information from the National Library of Medicine

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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:

  • Age≥18 years with estimated life expectancy >3 months.
  • Histopathological/cytological diagnosis of unresectable or recurrent / metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder) and had at least one measurable disease (≥1cm) by CT or MRI.
  • Patients should provide samples of tumor tissue biopsied or resected no more than 3 months before enrollment and be willing to accept biopsy in the process of the study.
  • Patients may have received prior radiotherapy,chemotherapy,or other local ablative therapies, which completed ≥ 4 weeks prior to registration AND patient has recovered to <= grade 1 toxicity.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
  • Adequate organ and marrow function obtained ≤ 2 weeks prior to registration as defined below:

leukocytes greater than or equal to 3.0 x 10^9/L absolute neutrophil count greater than or equal to 1.0 x 10^9/L platelets greater than or equal to 100 x 10^9/L hemoglobin greater than or equal to 90 g/L total bilirubin less than or equal to 2 xULN serum albumin should be no less than 25g/L ALT or AST less than 2 xULN serum creatinine less than 1.5 x ULN

  • Ability to understand and willingness to sign a written informed consent document.
  • women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and up to 120 days after the last dose of the drug.

Exclusion Criteria:

  • Active, known or suspected autoimmune diseases.
  • Known brain metastases or active central nervous system (CNS). If patients with CNS metastases were treated with radiotherapy for at least 3 months prior to enrollment and have no central nervous symptoms and are off corticosteroids, they will be eligible but will need a Brain MRI prior to enrollment.
  • Participants are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
  • Prior therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (including ipilimumab or any other antibody specifically targeting T-cell costimulation or checkpoint pathways).
  • History of severe hypersensitive reactions to other monoclonal antibodies.
  • History of allergy or intolerance to study drug components.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function.
  • Uncontrolled intercurrent illness including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
  • History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented.
  • Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Vaccination within 30 days of study enrollment.
  • Active bleeding or known hemorrhagic tendency.
  • Patients with unhealed surgical wounds for more than 30 days.
  • Being participating any other trials or withdraw within 4 weeks.

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): NCT03311789


Contacts
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Contact: Weidong Han, Ph.D +86-10-66937463 hanwdrsw@sina.com
Contact: Kaichao Feng, MD +86-10-55499341 timothyfkc@126.com

Locations
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China
Department of Biotherapeutic, Chinese PLA General Hospital Recruiting
Beijing, China
Contact: Weidong Han, Ph.D    +86-10-66937463    hanwdrsw@sina.com   
Contact: Kaichao Feng, MD    +86-10-55499341    timothyfkc@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Director: Weidong Han, Ph.D Department of Biotherapeutic, Chinese PLA General Hospital

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Responsible Party: Han weidong, Ph.D, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03311789     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-024
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
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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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cisplatin
Nivolumab
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
Antineoplastic Agents, Immunological