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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haining Health-Coming Biotech Co., Ltd.
• Collaborator: Alphacait, LLC

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).