Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers
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|ClinicalTrials.gov Identifier: NCT04211168|
Recruitment Status : Not yet recruiting
First Posted : December 26, 2019
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Biliary Tract Cancer||Drug: Toripalimab plus Lenvatinib||Phase 2|
This phase II trial is a single-arm, non-randomized and single-center clinical study.
It is estimated that 44 patients who met the study criteria will be enrolled in 2 years and treated with toripalimab plus lenvatinib in PUMCH. 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. Interim analysis and final analysis will be conducted when collecting data from 20 and 44 subjects, respectively in this trial. 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 :||44 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients are confirmed with advanced biliary tract cancers by imaging and histological examination and meet with the inclusive criteria, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct cancer and gallbladder cancer.|
|Masking:||None (Open Label)|
|Official Title:||Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers: a Single-arm, Non-randomized, Single-center Clinical Trial and Biomarker Study|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Toripalimab Plus Lenvatinib
Toripalimab (Shanghai Junshi Biosciences Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.
Lenvatinib is a novel angiogenesis inhibitor which targets multiple tyrosine kinases， including vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.
Drug: Toripalimab plus Lenvatinib
Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle.
Lenvatinib 8mg (weight<60kg) or 12mg (weight≥60kg), once a day, orally, day 2, 6 weeks a cycle. Dose reduction to 4mg/d or dose termination is allowed according to adverse events.
Number of cycle: until progression or unacceptable toxicity events develop.
Other Name: JS001 plus E7080
- Objective response rate (ORR) [ Time Frame: two years ]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.
- Rate of adverse events (AE) [ Time Frame: two years ]the incidence rate of any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
- Overall Survival (OS) [ Time Frame: two years ]Duration from the date of initial treatment to the date of death due to any cause.
- Progression-free Survival (PFS) [ Time Frame: six months ]A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.
- Stable Disease (SD) [ Time Frame: two years ]Proportion of patients with stable disease status more than 4 months.
- Clinical benefit rate (CBR) [ Time Frame: two years ]Proportion of patients achieved complete response and partial response for more than 6 months.
- Progression free survival rate [ Time Frame: 6 months ]Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with toripalimab plus lenvatinib for 3 months and 6 months, respectively.
- 6-months and 1-year mortality rate [ Time Frame: one year ]Portion of patients who die of any cause after treated with toripalimab plus lenvatinib at 6 months and 1 year, respectively.
- Biomarkers [ Time Frame: two years ]Any biomarker related with efficacy and safety.
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): NCT04211168
|Contact: Xu Yang, MD||+86 firstname.lastname@example.org|
|Contact: Haitao Zhao, MD|
|Study Chair:||Haitao Zhao, MD||Peking Union Medical College Hospital (PUMCH)|