Exploratory Clinical Study of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02942329|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : February 26, 2018
The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or gastric cancer.
Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.
SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Hepatocellular Carcinoma||Drug: apatinib Drug: SHR-1210||Phase 1 Phase 2|
Patients will received apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.
The dose escalation phase has completed for apatinib from 125mg, 250mg to 500mg. The dose of 250mg showed best tolerance and efficacy especially in hepatocellular carcinoma. Thus, for hepatocellular carcinoma patients, apatinib 250mg orally every day was chosed for the dose extension phase. In gastric cancer, the dose of 250mg also showed good tolerance but mild efficacy. Thus, for gastric cancer patients, the dose of 375mg daily for apatinib would be explored and then the investigators will decide the best dosage for these patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Clinical Study of the Combination of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric Cancer|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: apatinib and SHR-1210
Every patients will received apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effects.
Apatinib was administered 250mg or 375mg orally daily. For gastric cancer patients, the dose would be 250mg or 375mg daily. For hepatocellular carcinoma patients, the dose would be 250mg daily.
SHR-1210 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.
- Overall survival rate [ Time Frame: Up to approximately 12 months ]6 months and 12 months
- Tumor response rate [ Time Frame: Up to approximately 12 months ]
- Disease control rate [ Time Frame: Up to approximately 12 months ]
- Duration of response [ Time Frame: Up to approximately 12 months ]
- Safety as measured by the rate of AEs, deaths and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 ) [ Time Frame: From the first assignment of informed consent form up to 90 days after the last dose ]
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): NCT02942329
|Contact: Jian-Ming Xu, M.D.||+email@example.com|
|The Affiliated Hospital of the Chinese Academy of Military Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Jian-Ming Xu, M.D. +861066947176 firstname.lastname@example.org|
|Principal Investigator: Jian-Ming Xu, M.D.|
|Sub-Investigator: Yun Zhang, M.D.|
|Principal Investigator:||Jian-Ming Xu, M.D.||The Affiliated Hospital of the Chinese Academy of Military Medical Sciences|