Clinical Research Directory

A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma

The goal of this clinical trial is to learn whether the Ad5.F35-hGCC-PADRE vaccine is safe and can stimulate an immune response against gastrointestinal (GI) cancers in patients with pancreatic, colorectal, esophageal, gastric, or small bowel adenocarcinomas who have completed surgical resection and standard adjuvant therapy. An additional goal is to evaluate whether the vaccine may help eliminate minimal residual disease (MRD) in ctDNA-positive colon cancer patients. The main questions it aims to answer are: Is the Ad5.F35-hGCC-PADRE vaccine safe and tolerable at different dose levels? Does the vaccine induce GCC-specific T-cell immune responses in patients with GI malignancies? In ctDNA-positive colon cancer patients, can the vaccine promote ctDNA clearance as a marker of MRD elimination? The investigators will compare immune responses across different vaccine dose levels (10¹¹, 10¹², and 5 × 10¹² virus particles) to determine the optimal dose. Participants will: Receive the Ad5.F35-hGCC-PADRE vaccine by intramuscular injection. Be assigned to one of three dose levels during the dose-finding phase or receive a prespecified dose in the dose-expansion cohort. Undergo safety assessments, including monitoring for adverse events, injection-site reactions, and laboratory test abnormalities. Have blood samples collected to evaluate GCC-specific T-cell immune responses. For ctDNA-positive colon cancer patients, undergo ctDNA testing to assess clearance of minimal residual disease.

Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.