A Phase 1 interventional study of AL3810 and AL3810 in Advanced Solid Tumor and Advanced/Metastatic Colorectal Cancer, sponsored by Haihe Biopharma Co., Ltd.. Status unknown at 7 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-08-24.
Sponsored by Haihe Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment
This project intends to make a study of personalized medicine evaluation system establishment for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the development of Precision Medicine and personalized medicine for the patients of high-incidence-rates cancer in China.
Main criteria for inclusion:
Histologically or cytologically confirmed, locally advanced or metastatic solid tumor and be limited to:
Per RECIST v1.1 guidelines for solid tumors:
Adequate bone marrow and organ function as defined by the following laboratory values: (prophylactic use of myeloid growth factors (eg, G-CSF, GM-CSF) is prohibited within 2 weeks before screening)
Main criteria for non-inclusion
Previous treatment with Bevacizumab within 3 months of starting AL3810. In addition:
Patient has active cardiac disease or a history of cardiac dysfunction in screening including any of the following:
20 gastric carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Drug: AL3810
20 hepatocellular carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Drug: AL3810
20 Nasopharyngeal carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
Drug: AL3810
Fasting,oral ,4w on or 3w on/1w off
Fasting,oral ,4w on or 3w on/1w off
Fasting,oral ,4w on or 3w on/1w off
AE
the number of patients with grade 3 and 4 AE according to CTC AE 4.03
Time frame: through study completion, an average of 1 year
ORR
The proportion of patients who have observed overall remission (CR) or partial remission (PR) as the overall optimal remission based on the RECIST 1.1.
Time frame: through study completion, an average of 1 year
AUC
Area under the plasma concentration versus time curve
Time frame: up to 3 cycles(28 days/cycle)
Cmax
Peak Plasma Concentration
Time frame: up to 3 cycles(28 days/cycle)
DoR
All patients with the best overall response to CR or PR were required to calculate the duration of the response. This time is the duration (progression or death, whichever occurs first) from the first decision to CR or PR to tumor progression or death (death for any cause)
Time frame: through study completion, an average of 1 year
DCR
DCR refers to the percentage of patients who have achieved confirmation during the treatment of CR, confirmed PR and / or SD
Time frame: through study completion, an average of 1 year
PFS
To the date of randomization to the date of the onset of the disease or the date of death (regardless of the cause of the death) (whichever is the earlier).
Time frame: through study completion, an average of 1 year
CD4+/CD8+
cell count of CD4+/CD8+
Time frame: from baseline up to six months(every 8 weeks±7 days )
Growth factor
the content of growth factor such as VEGF,FGF and PDGF in plasma
Time frame: from baseline up to six months(every 8 weeks±7 days ), C1D15
Exosomes
the content of growth factor such as INFγ and cMyc in plasma
Time frame: from baseline up to six months(every 8 weeks±7 days )
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Haihe Biopharma Co., Ltd.