Status:
UNKNOWN
To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
A Phase 2 Study to Evaluate Adjuvant OBI-833/OBI-821 Therapy in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer at High Risk for Recurrence
Eligibility Criteria
Inclusion
- Male or female patients, 20 years of age or older at the time of consent.
- Pathologically or cytologically confirmed diagnosis of esophageal cancer (including squamous cell carcinoma and adenocarcinoma) whose postneoadjuvant pathologic stage is ypT1-4 AND ypN1-3 according to the AJCC Cancer Staging System, 8th Edition.
- Patients have been treated with preoperative cisplatin-based chemoradiotherapy followed by esophagectomy with lymph node dissection for locally advanced esophageal cancer (defined by the above criterion).
- Postneoadjuvant pathologic staging: ypT1-4 and ypN1-3.
- Globo H IHC H-score ≥1 in the surgical tumor specimen from the primary site/or lymph node (if the primary site is not available). The Globo H expression will be determined by a qualified laboratory.
- R0 (no residual tumor on the surgical margin of the resected tumor specimen).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Organ Function Requirements - Subjects must have adequate organ functions as defined below:
- AST/ALT ≤ 3X ULN (upper limit of normal)
- Total bilirubin ≤ 2X ULN
- Serum creatinine ≤ 1.5X ULN
- ANC ≧ 1,500 /μL
- Platelets ≧ 100,000/μL
- All eligible patients of childbearing potential must use effective contraception during study treatment and for at least 2 months after the last dose of OBI-833/OBI-821. Subjects not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
- Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
Exclusion
- Subjects who cannot be randomized within 8 weeks after the esophageal cancer surgery.
- Subjects who are pregnant or breast-feeding at entry.
- Subjects with splenectomy.
- Has prior malignancy, except (a) adequately treated basal cell or squamous cell skin cancer; (b) in situ cervical cancer; (c) previously diagnosed malignancy which has been adequately treated and shown no evidence of recurrence for more than 5 years.
- Subjects with HIV infection, active hepatitis B infection, or active hepatitis C infection.
- Subjects with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
- \- e.g., type 1 juvenile-onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graves disease, Hashimoto thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, Crohn disease, ulcerative colitis, and psoriasis.
- Subjects with any known uncontrolled comorbid illness, including ongoing or active infections, symptomatic congestive heart failure (NYHA\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects who have received any of the following medications within 4 weeks prior to randomization:
- Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors.
- Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide.
- Other biologics, including G-CSF and other hematopoietic growth factors.
- Live attenuated vaccines.
- IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. Use of inhaled and topical (except on the injection site) steroids is allowed.
- Alternative and complementary medicine that may affect the immune system.
- Other investigational drugs
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
- Subjects with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.
- Any other reason that the investigator deems the patient as unsuitable for the study.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05376423
Start Date
June 2 2022
End Date
June 1 2025
Last Update
November 15 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan