Evaluation of safety and efficacy of colon cancer stem cell target immunotherapy

Phase 1

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000034537
• Lead Sponsor: Sapporo medical university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

(1) HIV positive. (2) Heart disease under NYHA III or IV classification. (3) Uncontrollablediabetes/hypertension. (4) Pleural effusion/pericardial fluid/ascites). (5) Autoimmune disease. (6) History of interstitial pneumonia. (7) Organ transplantation (including hematopoietic stem cell transplantation) (8) Life-threatening diseases. (9) History of immune cell therapy for cancer. (10) 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. (11) Use of Sho-sai-koto/warfarin/ theophylline. (12) Steroids use required. (13) History of severe drug allergy. (14) Sensitive to cow materials. (15) Sensitive to biological preparation. (16) Severe psychosis/neurologic manifestation. (17) Pregnant/lactating. Hope to conceive during trial/unable to use contraception. (18) Disqualified for trial by principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Safety 2) Immunological response

Secondary Outcome Measures

Name	Time	Method
1) Disease Control Rate 2) Progression-Free Survival