Pancreatic cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Tocilizumab (Genetical Recombination)
INN of investigational material : tocilizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Adm
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent for participation in the study is obtained at the discretion of the patient. 2. Metastatic pancreatic cancer with histologically or cytologically confirmed diagnosis of adenocarcinoma 3. Patients with progressed pancreatic cancer after treatment with GEM/nab-PTX achieved complete, partial response (PR) by the Response Evaluation Criteria in Solid Tumours (RECIST) guideline version 1.1, or equivanlent to PR (more than 20% tumor shrinkage or more than 50% reduction of tumor marker, such as CA19-9) for unresectable or recurrent pancreatic cancer 4. GEM (750 mg/m2) and nabPTX (100 mg/m2) is judged to be tolerable when GEM/nabPTX is rechallenged 5. Measurable disease based on RECIST version 1.1. 6. serum CRP level >=0.5 to <10.0 mg/dL
Exclusion criteria
Exclusion criteria: 1. Severe effusion or edema 2. Symptomatic brain metastasis 3. Active concomitant malignancy 4. Prior choledochojejunostomy 5. Transfusion within 4 weeks before enrollment 6. Major surgery excluding biliary drainage percutaneously or endoscopically within 4 weeks before enrollment 7. Scheduled surgery during the study treatment 8. Prior IL-6 signal blocker treatments including JAK inhibitors 9. Prior immunotherapy including cancer vaccine, immune-checkpoint inhibitor, and so on 10. Prior treatment with biologics including TCZ, trastuzumab, Infliximab, etanersept and adalimumab within 4 weeks before enrollment 11. Active infectious diseases requiring systemic administration of antibiotics, antivirals, antifungals, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Frequency of adverse events - Occurrence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics - Pharmacokinnetics of TCZ - Objective response rate: ORR - Disease control rate: DCR -Progression-free survival: PFS -MDASI-J; Symptom scores and Interference scores | — |
Countries
Japan
Outcome results
None listed