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Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor

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: NCT03299452
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Alphacait, LLC
Information provided by (Responsible Party):
Haining Health-Coming Biotech Co., Ltd.

Study Description
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Brief Summary:
This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Drug: Non Chemotherapy Drug: Chemotherapy and target therapy Drug: Chinese herb medicine Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Alphacait-guided therapy
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued.
 Drug: Non Chemotherapy
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Drug: Chemotherapy and target therapy
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Drug: Chinese herb medicine
Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival(PFS) [ Time Frame: 36 months ]
    Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 36 months ]
    Defined as the time from assignment to death from any cause.

  2. Overall response rate (ORR) [ Time Frame: 36 months ]
    Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy

  3. Disease control rate(DCR) [ Time Frame: 36 months ]
    Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response or stable disease to therapy

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 36 months ]
    Drug-related adverse reactions must be recorded, mainly in the following：myelosuppression including neutropenia, anemia and thrombocytopenia;Cardiac toxicity; muscle fatigue, pain, imbalance; Oral ulcers: the patient's gums, cheeks, throat and tongue are prone to ulcers;nausea, vomiting, constipation or diarrhea;hair loss;skin discomfort;hormonal fluctuations, sexual dysfunction, infertility; damage of the kidney;anxiety and depression.

  5. Biomarkers [ Time Frame: 36months ]
    Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry (IHC) or quantitative reverse transcription polymerase chain reaction (qRT-PCR), a new generation sequencing method (NGS), Nanostring technique and / or other methods to evaluate archived and/or newly acquired tumor tissue, as well as its association with disease status and/or (Including but not limited to somatic mutations and other exploratory markers) according to qRT-PCR and NGS techniques, and to evaluate the relationship between the therapeutic response, the status of the biomarker during exploratory treatment and during treatment, and the evaluation of plasma, serum or whole blood samples (including but not limited to somatic mutations and other exploratory markers) The association of the above markers with disease status and / or therapeutic response.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced recurrent or metastatic malignant tumor confirmed by pathological diagnosis;
  2. At least one measurable malignant lesion;
  3. Failed previous standard treatment or with tumor recurrence, and no standard therapeutic regimen available;
  4. No radiation therapy within last four weeks or recovered from last radiation related acute complication, if applicable; prophylactic brain radiation therapy or palliative radiation treatment for bone metastasis is acceptable;
  5. No gender requirement and must be no younger than18 years old;
  6. ECOG PS: score 0-2;
  7. Life expectancy more than three months;
  8. Patient's organ function level should meet these criteria:

(1) CBC should meet these criteria: ANC≥1.5×109 /L，PLT≥100×109/L，Hb≥ 100 g/L; (2) Chemistry should meet these criteria: TBIL＜1.5×ULN，ALT、AST＜ 2.5×ULN（if with liver metastasis ALT、AST＜5×ULN） BUN and Cr ≤1×ULN or Cr clearance ≥50ml/min（Cockcroft-Gault formula） 9. Agree to use appropriate contraceptive measure during the study period and until 8 weeks after the last study drug is given. Or patient has been surgically sterilized.

10. Qualified candidate should voluntarily participate this study, sign informed consent forms and be compliant with the study protocols and follow-up visit(s).

Exclusion Criteria:

  1. Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
  2. Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male>450 ms, female>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) <50%;
  3. History of pulmonary interstitial lung disease or active interstitial lung disease;
  4. Coagulation dysfunction (INR >1.5 or PT>ULN+ 4sec, or PTT>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
  5. Clinical bleeding episode or bleeding tendency within past three months, such as GI bleeding, hemorrhagic gastric ulcer, stool guaiac++ positive, or with vasculitis；
  6. Arterial or venous thrombosis within last 12 months, such as various types of CVA, DVT or PE patients;
  7. Known hereditary or acquired bleeding or hypercoagulable state (such as hemophilia, coagulating dysfunction, thrombocytopenia, hypersplenism);
  8. Major surgery, trauma, fracture or ulcer within past 4 weeks;
  9. Active infection requiring antibiotics, antifungal or antiviral treatment;
  10. Patient has a history of psychiatric medication abuse and cannot be abstinent from the psychiatric medication, or with mental disorder;
  11. Participation of other cancer chemotherapy clinical study within past 4 weeks;
  12. History of uncured coexisting cancer, no including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer;
  13. Pregnant or breast feeding women; fertile patients no willing or able to take effective contraceptive measures;
  14. Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s).
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03299452


Contacts
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Contact: Bin Li, MD 86-137-50766911 yanfangren1019@gmail.com
Contact: Haizhou Lou, MD 86-571-86006926 louhz09@aliyun.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Haizhou Lou, MD    86-571-86006926    louhz09@aliyun.com   
Contact: Ming Xu    86-571-86006811    xuminghnu@126.com   
Principal Investigator: Haizhou Lou, MD         
Sponsors and Collaborators
Haining Health-Coming Biotech Co., Ltd.
Alphacait, LLC
Investigators
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Principal Investigator: Haizhou Lou, MD Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
Principal Investigator: Linghua Zhu, MD Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
Principal Investigator: Enguo Chen, MD Sir Run Run Shaw Hospital, affiliated with Zhejiang University, School of Medicine
More Information
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Responsible Party: Haining Health-Coming Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03299452    
Other Study ID Numbers: Alphacait 001
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through publication after study completion
Supporting Materials: Study Protocol
Time Frame: 12/31/2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haining Health-Coming Biotech Co., Ltd.:
ex vivo high-throughput drug screening assay
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes