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.

Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.

Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.

Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma

This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, 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. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.