Study on Oral TGF-beta Receptor I Inhibitor Vactosertib with Standard Chemoradiotherapy for Esophageal Cancer

Sponsor: Sakti Chakrabarti

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06044311

Provider View

This clinical trial is exploring whether adding a new pill called vactosertib to the usual treatment of chemotherapy and radiation can improve outcomes for people with esophageal cancer. Participants will take vactosertib before and after their standard treatment to see if it helps reduce cancer cells.

Patient Parameters

Program Overview

The study aims to improve treatment for esophageal cancer by using a new drug, vactosertib, which targets a protein called TGF-beta. Participants will take vactosertib for two weeks before starting their usual chemotherapy and radiation treatment. After this period, they will have a PET CT scan and an endoscopy with a biopsy to check if the drug is working. Following the standard treatment, participants will take vactosertib again for four weeks before being considered for surgery.

Description

Esophageal adenocarcinoma is a challenging cancer to treat, with limited options available. For those with localized cancer, the standard approach is to use chemotherapy and radiation before surgery, which helps some patients but not all. This study is testing a new drug, vactosertib, which targets a specific protein involved in cancer growth. By adding vactosertib to the standard treatment, researchers hope to improve the chances of reducing the cancer before surgery. Participants will take vactosertib before and after their usual treatment, and their progress will be monitored through scans and biopsies.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with poorly differentiated or Grade 3 esophageal or gastroesophageal junction adenocarcinoma, at clinical Stage II or III.
  • Suitable for standard chemoradiotherapy with carboplatin and paclitaxel or FOLFOX.
  • Considered a potential candidate for surgery by a qualified surgeon.
  • No previous chemotherapy, immunotherapy, or radiation for this cancer.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Normal organ and blood function based on specific tests.
  • No issues with receiving standard chemotherapy or radiation.
  • Women and men must agree to use effective birth control during the study and for six months after.
  • Able to understand and sign a consent form.
  • Able to swallow pills and willing to undergo necessary tests and procedures.

Exclusion Criteria

  • Currently taking other experimental drugs.
  • Have had another active cancer in the past three years, except for certain skin or localized cancers.
  • Allergic to any of the study drugs.
  • Unable to receive radiation or standard chemotherapy.
  • Have uncontrolled health issues like infections or heart problems.
  • Pregnant or breastfeeding women.
  • HIV-positive or have untreated hepatitis B or C.
  • Taking certain medications that interact with vactosertib.
  • Have a specific heart condition as shown by an ECG.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.