Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs
NCT ID: NCT03311789
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2017-05-01
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chinese PLA General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Han weidong
Ph.D
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Weidong Han, Ph.D
Role: STUDY_DIRECTOR
Department of Biotherapeutic, Chinese PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Biotherapeutic, Chinese PLA General Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Weidong Han, Ph.D
Role: primary
Kaichao Feng, MD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Feng K, Liu Y, Zhao Y, Yang Q, Dong L, Liu J, Li X, Zhao Z, Mei Q, Han W. Efficacy and biomarker analysis of nivolumab plus gemcitabine and cisplatin in patients with unresectable or metastatic biliary tract cancers: results from a phase II study. J Immunother Cancer. 2020 Jun;8(1):e000367. doi: 10.1136/jitc-2019-000367.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHN-PLAGH-BT-024
Identifier Type: -
Identifier Source: org_study_id