Locally Advanced Pancreatic Adenocarcinoma.
Conditions
Interventions
Group A:Novaferon, intramuscular injection, 10ug, thrice weekly for week 1-13
Group B:Novaferon, intramuscular injection, 10µg, thrice weekly for week 1
followed by 20µg, thrice weekly for week 2-13
Group C:Scheme A or Scheme B according to the first stage result
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of Locally Advanced Pancreatic Adenocarcinoma; 2. At least 4 weeks since prior cytotoxic chemotherapy, interventional therapy or targeted therapy and must have recovered from them completely; 3. measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST); 4. KPS>=70; 5. Life expectancy >=12 weeks; 6. Female: Women of childbearing potential must have a negative serum or urine pregnancy test at screening, and use an approved contraception. Male: Must be surgically sterile or compliant with an adequate contraception during, and for 3 months after the treatment; 7. The signed informed consent must be obtained prior to performing any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergy to interferon-alpha drugs or already generated interferon-alpha antibodies; 2. Patients who have received radiation therapy; 3. Received any other investigational agents or non-approved drugs within 4 weeks preceding the first dose of investigational product; 4. Patients who are receiving other antiviral therapies at the same time; 5. Concurrent anti-tumor therapy during the study; 6. Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (CR+PR +SD)%;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL;CBR; | — |
Countries
China
Contacts
Public ContactZhaoshen Li
Department of Gastroenterology, Changhai Hospital, The Second Military Medical University
Outcome results
None listed