STNM-FNI

JRCT ID: jRCT2031190055

Registered date:16/07/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 08/04/2019
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Study drug STNM01 will be administered intratumorally using 22G needle through EUS-FNI.

Outcome(s)

• Primary Outcome: To determine the dose-limiting toxicity (DLT) at week 6.

Secondary Outcome

[ Safety ] Adverse effects and adverse drug reactions.
[ Efficacy ] Overall survival (OS), Progression free survival (PFS), Tumor response, Patient reported outcome (PRO)
[ PK ] Plasma drug concentration
[ Serum tumor markers ] CA19-9, CEA
[ Histological examination ] HE, immunostaining for CHST15, CD44v6, CD44v9, CD3, CD8, CD20.
[ Serum adhesion molecule ] Soluble CD44 variant 6

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion Criteria:
1)The subject' s age is 20 or older at the time of informed consent.
2)The subjects that is confirmed as pancreatic cancer with histopathological or imaging diagnosis and is clinically diagnosed as unresectable pancreatic cancer.
3)The subject has been treated before the screening tests by conventional first-line drug(s) generally used to treat pancreatic cancer [e.g.. Gemcitabine, S-1] and has confirmed as an insufficient response, resistance or intolerant with imaging or clinical findings.
4)The subject has at least one measurable disease [Disease of a maximum diameter with > 10 mm].
5)The subject has an ECOG Performance Status of 0 or 1.
6)The subject has an ability of oral intake.
7)The subject is able to comply with the visit schedule and study procedures, including follow-up visits.
8)The subject has white cell count >= 3,000/mm3, platelets >=75,000/mm3, hemoglobin >= 10 g/dL, AST <= 100 IU/L, ALT<= 100 IU/L, serum creatinine <= 2.0 mg/dL, Albumin >= 2.5 g/dL within 28 days prior to registration.
9)The subject signs and dates a written informed consent to participate in the study.

Exclude criteria

1)The subject has or has a history of serious cardiac, hematological or pulmonary disease.
2)The subject has moderate to severe ascites and/or pleural effusion.
3)The subject has a symptom related to brain metastasis or a history of metastatic brain tumor.
4)The subject has other malignancy that would interfere with the current intervention.
5)The subject has a complication of serious infection that requires hospitalization.
6)The subject has a severe complication such as intestinal paresis, ileus, uncontrollable diabetes mellitus, heart failure, liver failure, renal failure.
7)The subject has or has a history of clinically serious allergic symptom.
8)The subject has a bleeding tendency.
9)The subject has a medical condition contraindicated for EUS.
10)The subject is currently participating or plans to participate in another clinical study during the course of this study.
11)The subject has any psychiatric or neurological disorder, and is unsuitable, in the investigator's opinion, to participate in the study.
12)The subject is incapable of or restricted to the protocol-directed examinations or procedures.
13)For females: pregnancy or lactation.
14)The subject positive for HBs antigen, HCV antibody or serological test for syphilis.
15)The subject is considered by the investigator, for any other reason, to be unsuitable for participating in this study.

Related Information

• Primary Sponsor: Yahagi Naohisa
• Secondary Sponsor: Japan Agency for Medical Research and Development