An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03989310|
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Manganese Chloride Drug: nab-paclitaxel Drug: Gemcitabine Drug: anti-PD-1 antibody||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-label, One-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Pancreatic Cancer|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: ed anti-PD-1 antibody plus nPG chemotherapy
Subject 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.
Drug: Manganese Chloride
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Other Name: Paclitaxel For Injection (Albumin Bound)
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Name: Anti-PD-1 monoclonal antibody; PD-1 inhibitor
- Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: 12 months ]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.
- Disease control rate (DCR) [ Time Frame: 12 months ]DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Object response rate (ORR) [ Time Frame: 12 months ]ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Progression-free survival (PFS) [ Time Frame: 12 months ]PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.
- Overall survival (OS) [ Time Frame: 24 months ]OS time was measured from the study entry to the date of death.
- Number of participants with laboratory test abnormalities [ Time Frame: 12 months ]The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.
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): NCT03989310
|Contact: Weidong Hanfirstname.lastname@example.org|
|Biotherapeutic Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, M.D +86-10-66937463 email@example.com|
|Contact: Qingming Yang, M.D +86-10-55499341 firstname.lastname@example.org|
|Principal Investigator: Weidong Han, M.D|
|Principal Investigator: Qian Mei, M.D|
|Principal Investigator: Qingming Yang, M.D|
|Principal Investigator: Meixia Chen, M.S.|
|Sub-Investigator: Yan Zhang, M.S.|
|Sub-Investigator: Kaichao Feng, M.S.|
|Sub-Investigator: Yang Liu, M.D.|
|Sub-Investigator: Jiejie Liu, B.S.|
|Sub-Investigator: Xiang Li, B.S.|
|Sub-Investigator: Liang Dong, M.D.|