Oral TGF-beta Receptor I Inhibitor Vactosertib in SOC Chemoradiotherapy for Esophageal Adenocarcinoma

Conditions

• Adenocarcinoma Esophagus
• Locally Advanced Adenocarcinoma
• Siewert Type I Adenocarcinoma of Esophagogastric Junction
• Siewert Type II Adenocarcinoma of Esophagogastric Junction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vactosertib — DRUG
  300 mg orally, twice daily for five days a week, for 2 weeks and again for 2 weeks after completion of preoperative therapy.
• Standard of Care Preoperative Therapy — DRUG
  Preoperative therapy will NOT be determined by the clinical trial protocol. It will be determined per standard of care by the treating physician and participant. Preoperative therapy will either be FLOT for 8 weeks OR concurrent radiation and chemotherapy (carboplatin and paclitaxel or FOLFOX) for 5-6 weeks, per standard of care.

Study Details

This interventional clinical trial aims to find ways of improving treatments for individuals with esophageal cancer. Laboratory-based studies show that using medicines that affect a protein called TGF-beta (TGFβ) can kill esophageal cancer cells in individuals who have localized esophageal adenocarcinoma and are being considered for standard-of-care chemoradiation prior to surgery. Participants of this study will take a pill called vactosertib for two weeks before starting standard of care therapy. At the end of the two weeks of taking vactosertib, participants will have a Positron Emission Tomography Computer Assisted Tomography (PET CT) scan and undergo an endoscopy with a biopsy to determine if the vactosertib is working. After standard of care therapy, participants will take vactosertib again for two weeks and then be considered for surgery.

Key Dates

First listed

Sep 21, 2023

Start date

Sep 30, 2024

Status verified

Sep 2026

Primary completion

Mar 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Vactosertib + Preoperative therapy
  Vactosertib orally, 300 mg twice daily for five days a week for 2 weeks, followed by standard of care preoperative therapy, followed by Vactosertib for 2 weeks after standard of care preoperative therapy

Primary Outcome Measure

Metabolic Response [ Time Frame: At two weeks post treatment ]

Central Contacts

• Melissa Lumish, MD
  216-844-3951
  [email protected]

Locations (1)

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