A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment.

A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment. - Phase II clinical study of vaccine therapy using survivin-2B peptide/STI01 for patients with advanced or recurrent pancreatic cancer. (SUCCESS-II)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012146

Enrollment

Registered

2013-11-01

Start date

2013-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

SVN-2B(Placebo),STI-01(Placebo) SVN-2B,STI-01(Placebo) SVN-2B,STI-01

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with a definitive diagnosis of pancreatic adenocarcinoma or invasive ductal carcinoma of pancreas. (2)Patients with expression of survivin protein in cancer cells. (3)Patients must meet all of the following criteria. a)Patients with inoperable status like distant metastasis, local recurrence or locally advanced cancer. b)Patients with cancer which did not respond or intolerable to gemcitabine or TS-1. c)Patients who could not receive or refused to receive either gemcitabine or TS-1. (4)Patients with measurable lesion based on RECIST as determined by CT or MRI at screening period. (5)Patients with HLA-A*2402 positive. (6)Patients with ECOG Performance Status 0 or 1. (7)Patients without serious organ failure within 30 days prior to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75*103/uL, 1.5 times serum creatinine level <= normal upper limit level, 3 times total serum bilirubin level <= normal upper limit level, AST and ALT <=3 times normal upper limit level). (8)Patients aged 20-85 years when providing informed consent. (9)Patients who have received sufficient explanation of this trial.

Exclusion criteria

Exclusion criteria: (1)HIV positive. (2)Heart disease under NYHA III or IV classification. (3)Uncontrollablediabetes/hypertension. (4)Pleural effusion/pericardial fluid/ascites). (5)Brain metastatic. (6)Multiple malignancies. (7)Autoimmune disease. (8)Under suspicion of severe inflammatory disease. (9)History of interstitial pneumonia. (10)Life-threatening diseases. (11)History of immune cell therapy for cancer. (12)Received followingtreatmentdesignated period prior to registration. a)Surgery/radiotherapy. b)Chemotherapy. c)Endocrine therapy/immunotherapy. d)Blood transfusion/hematopoietic factor. e)Application of immunosuppressive drug. f)Investigational/unlicensed drugs. (13)Use of Sho-sai-koto/warfarin/ theophylline. (14)Steroids use required. (15)History of severe drug allergy. (16)Sensitive to cow materials. (17)Sensitive to biological preparation.(18)Severe psychosis/neurologic manifestation. (19)Pregnant/lactating. Hope to conceive during trial/unable to use contraception.(20)Disqualified for trial by principal investigator.

Design outcomes

Primary

Measure	Time frame
Time to progression	—

Secondary

Measure	Time frame
1)Immunological response a)SVN-2B peptide specific CTL number (Tetramer analysis) b)SVN-2B peptide specific CTL activation(ELISPOT analysis) 2)Anti-tumor effect based on RECIST guideline 3)Safety a)Adverse Effect b)Laboratory Data	—

Countries

Japan

Contacts

Public ContactToshihiko Torigoe

Sapporo medical university Department of Pathology(I)

torigoe@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026