Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors
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|ClinicalTrials.gov Identifier: NCT04010071|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatobiliary Neoplasm Liver Neoplasm Biliary Tract Neoplasms||Drug: axitinib plus toripalimab||Phase 2|
This phase II trial is a single-arm, non-randomized and single-center clinical study.
It is estimated that 60 patients who met the study criteria will be enrolled in PUMCH and treated with axitinib plus toripalimab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression, until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.
Study Type: Interventional. Masking: Open Label.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients were confirmed with advanced hepatobiliary malignancies by imaging and histological examination and meet with the inclusive criteria, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma, and mixed cancer).|
|Masking:||None (Open Label)|
|Official Title:||Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors: a Single-arm, Non-randomized, Single-center Phase II Trial|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: axitinib plus toripalimab
Axitinib (Inlyta, Pfizer Inc.) is a novel oral angiogenesis inhibitor that selectively targets vascular endothelial growth factor (VEGFR) 1, 2 and 3.
Toripalimab (Shanghai Junshi Biosciences Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.
Drug: axitinib plus toripalimab
Axitinib 5mg, twice a day, orally, 4 weeks a cycle. Dose reduction from 5mg twice a day to 3mg twice a day should be considered according to adverse events.
Toripalimab 240mg, every 3 weeks, intravenous infused, 6 weeks a cycle. Number of cycle: until disease progression or unacceptable toxicity events.
- objective response rate (ORR) [ Time Frame: one year ]Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
- Progression-free Survival (PFS) [ Time Frame: six months ]A duration from the date of initial treatment with axitinib plus toripalimab to disease progression (defined by RECIST 1.1) or death of any cause.
- Disease Control Rate (DCR) [ Time Frame: one year ]Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
- Overall Survival (OS) [ Time Frame: two years ]Duration from the date of initial treatment with axitinib plus toripalimab to the date of death due to any cause.
- Duration of Response (DOR) [ Time Frame: one year ]Duration from the first time reported partial response or complete response to the first time of disease progression or death.
- Stable Disease (SD) [ Time Frame: one year ]Proportion of patients with stable disease status more than 4 months.
- Progression free survival rate [ Time Frame: six months ]Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with axitinib plus toripalimab for 3 months and 6 months, respectively.
- Rate of 6-months and 1-year overall survival [ Time Frame: one year ]Portion of patients who die of any cause after treated with axitinib plus toripalimab for 6 months and 12 months, respectively.
- Any adverse events related with treatment with axitinib plus toripalimab. [ Time Frame: one year ]Safety and tolerability of the treatment
- PD-L1 expression [ Time Frame: six months ]PD-L1 expression in tumor tissues.
- Tumor mutation burden [ Time Frame: six months ]Tumor mutation burden assessed by whole exome sequencing.
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): NCT04010071
|Contact: Jianzhen Lin, MD||+86 firstname.lastname@example.org|
|Contact: Haitao Haitao, Prof|
|Peking Union Medical College Hospital||Not yet recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Jianzhen Lin, MD +86-18800158133 email@example.com|
|Contact: Xiao-Bo Yang, MD +86-138-1167-5126 firstname.lastname@example.org|
|Principal Investigator: Hai-Tao Zhao, MD|
|Study Chair:||Haitao Haitao, Prof||Peking Union Medical College Hospital (PUMCH)|