Status:
UNKNOWN
Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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/cisplati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03311789
Start Date
May 1 2017
End Date
October 1 2019
Last Update
October 17 2017
Active Locations (1)
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1
Department of Biotherapeutic, Chinese PLA General Hospital
Beijing, China