Substudy 06A: Phase 1/2 Umbrella Study of Combination Therapies in Esophageal Cancer
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Registration Number
- JPRN-jRCT2031220197
- Lead Sponsor
- Shimoyama Ryo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC.
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications.
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to =<Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have =<Grade 2 neuropathy are eligible
- Direct invasion into adjacent organs such as the aorta or trachea.
- Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method