A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer
1 other identifier
interventional
20
1 country
1
Brief Summary
Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJuly 9, 2019
July 1, 2019
1.5 years
June 28, 2019
July 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
12 months
Progression-free survival (PFS) at 6 months
Progression free survival (PFS) at 6 months in patients with local advanced /metastatic BTCs treated with the combined regimen. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (RECIST V1.1) definition
6 months
Secondary Outcomes (4)
Disease control rate (DCR)
12 months
Object response rate (ORR)
12 months
Overall survival (OS)
24 months
Number of participants with laboratory test abnormalities
12 months
Study Arms (1)
Manganese primed anti-PD-1 antibody plus nPG chemotherapy
EXPERIMENTALSubject received Manganese primed anti-PD-1 antibody, nab-paclitaxel and gemcitabine every 3 weeks until achieving a second assessable stable disease or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent.
Interventions
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle
Eligibility Criteria
You may qualify if:
- ≥ 18 years old.
- Life expectancy of at least 3 months.
- Subjects must have Histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder).
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
- Subjects 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.
- Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
- Adequate organ function.
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
You may not qualify if:
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 1, 2019
Study Start
March 1, 2019
Primary Completion
August 31, 2020
Study Completion
August 31, 2021
Last Updated
July 9, 2019
Record last verified: 2019-07