Active — Not RecruitingPhase 2

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

United States48 participantsStarted 2020-11-10

Plain-language summary

This phase IIA trial investigates the side effects of Ad5.F35-hGCC-PADRE vaccine and to see how well it works in treating patients with gastrointestinal adenocarcinoma. Ad5.F35-hGCC-PADRE vaccine may help to train the patient's own immune system to identify and kill tumor cells and prevent it from coming back.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subjects with tumors specified below, who are at high risk of relapse, have been treated with curative intent, and have no evidence of disease (NED) following front-line therapy with surgery, radiation therapy, and/or chemotherapy. NED includes, where applicable, surgical (macroscopic tumor margin, at the time of surgery), and radiological evidence of disease. Residual lesions identified by microscopic/frozen margins and biochemical markers are permitted. Therapy must have been completed no fewer than four weeks, and no later than 25 weeks, before the first dose of Ad5.F35-hGCC-PADRE * For tumor-specific criteria, please refer to the information below: \* Pancreatic ductal adenocarcinoma \*\* Stage I, II, III * Neuroendocrine tumors of the pancreas are not permitted \* Colorectal adenocarcinoma * Stage III; stage IV following metastasectomy \* Gastric adenocarcinoma * Stage IIA, IIB, III * Gastrointestinal stromal tumors of the stomach are not permitted \* Esophageal adenocarcinoma \*\* Stage IIB, III * Esophageal squamous cell carcinomas are not permitted * Have an anticipated life expectancy of greater than 12 weeks * Absolute neutrophil count (ANC) \>= 1000 cells/mL * Platelets \>= 75,000 /mL * Hemoglobin \>= 9.0 g/dL * Serum creatinine \< 2.0 mg/dL * For other blood and urine tests including blood chemistry, hepatic and renal funct…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events (AEs)

Timeframe: 13 weeks

Antigen-specific T-cell response to guanylyl cyclase C (GCC)

Timeframe: 13 weeks

Trial details

NCT IDNCT04111172

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma trials