JPRN-jRCT2031210046
Suspended
Phase 1
A phase Ib study of durvalumab (MEDI4736) tremelimumab combined with particle therapy in advanced hepatocellular carcinoma patients with macrovascular invasion - DEPARTURE trial
Ogasawara Sadahisa0 sites15 target enrollmentApril 22, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ogasawara Sadahisa
- Enrollment
- 15
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol\-related procedures, including screening evaluations. For patients aged \>\=20 years and enrolling, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- •2\.Age \>\=20 years at time of study entry
- •3\.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •4\.Body weight \>30 kg
- •5\.Adequate normal organ and marrow function as defined below:
- •Haemoglobin \>\=9\.0 g/dL
- •Absolute neutrophil count (ANC) \> 1500 per mm3
- •Platelet count \>\=75 x 109/L (\>\=75,000 per mm3\)
- •Serum bilirubin \=\<3\.0 x institutional upper limit of normal (ULN)
- •AST (SGOT)/ALT (SGPT) \=\<2\.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be \=\<5x ULN
Exclusion Criteria
- •1\.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2\.Participation in another clinical study with an investigational product during the last 4 weeks, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study
- •3\.Any unresolved toxicity NCI CTCAE Grade \>\=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •Patients with Grade \>\=2 neuropathy will be evaluated on a case\-by\-case basis after consultation with the Study Physician.
- •Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the Study Physician.
- •4\.Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- •5\.Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- •6\.History of allogenic organ transplantation.
- •7\.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease], diverticulitis \[with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- •Patients with vitiligo or alopecia
Outcomes
Primary Outcomes
Not specified
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