K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open and single-center Phase I clinical research on patients with advanced pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to determine the safe and reasonable dosage and dosing regimen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Criteria

Inclusion Criteria:

Disease-related criteria for inclusion:

1. Based on histodiagnosis or cytodiagnosis;

2. Locally advanced or metastatic pancreatic adenocarcinoma;

3. Failure of standard treatment, >28 days after the last chemotherapy;

4. Patients not suitable for or having given up standard treatment;

5. At least one lesion measurable according to RECIST V 1.0 criteria;

6. ECOG score: 0～1;

7. Expected survival: ≥3 months;

Haematological, biochemical and organ functions:

8. Hematological indices:

• Absolute neutrophil count: ≥1.5×109/L;

• Platelet count: ≥80×109/L;

• Hemoglobin: ≥9.0 g/dL.

9. Total bilirubin: ≤1.5 x ULN, albumin: ≥3.0g/dL;

10. Patients without liver metastasis: ALT (SGPT) & AST (SGOT) ≤3.0 x ULN Patients with liver metastasis: ALT (SGPT) & AST (SGOT)≤5.0 x ULN;

11. Renal functions: serum creatinine ≤ 1.5xULN, Ccr ≥ 60ml/min (Cockcroft-Gault);

General criteria for inclusion:

12. Age: 18～70;

13. Letter of Consent signed by the patient or his/her legal representative:

14. Women of childbearing age must have a urine pregnancy test within 7 days before starting treatment, only negative results shall be included in the group. Male and female patients of childbearing age have agreed to use a reliable method of contraception before and during participating the study as well as 90 days (at least) after withdrawal.

Exclusion Criteria:

Disease-related criteria for exclusion:

1. Patients of pancreatic tumor but not adenocarcinoma;

2. Having received radiotherapy for his/her target lesions prior to this study, with no progress;

3. Known presence of brain metastases or leptomeningeal metastases;

4. With Vater's ampulla cancer or bile duct cancer;

5. Partial or complete intestinal obstruction;

6. History of other malignancies in past five years, except for:

• A consecutive 5-year disease-free survival from single surgery of other malignancies;

• Cured basal cell carcinoma and cured cervical carcinoma in situ.

General criteria for exclusion:

7. Pregnant or breast-feeding women;

8. Any unstable systemic disease, including: active infection; hypertension uncontrollable by medication (≥160/100mmHg); unstable angina, or angina with the onset from within the last three months; congestive heart failure (≥level II according to New York Heart Association [NYHA], see Annex 4); myocardial infarction occurred within 1 year before the enrollment; severe arrhythmias requiring medical treatment; and mental disorders, etc.;

9. Presence of active hepatitis B (history of hepatitis B infection, whether with or without medication, HBV DNA≥104 copy number or ≥2000u/ml) or HCV-Ab positive; known HIV-positive patients (no clinical signs or symptoms suggesting exemption of HIV test for HIV-infected individuals);

10. Having received any of the following treatment within specific time period before inclusion:

• Having had a major surgery within 4 weeks before inclusion;

• Having received expanded scope of radiotherapy within 4 weeks, or having received limited scope of radiotherapy within 2 weeks before inclusion;

• Having participated in any other therapeutic/interventive clinical trials within 4 weeks before inclusion, or taking part in an ongoing trial.

11. With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment;

12. Not fitting in the study, as conceived by the researcher.