Can a vaccine stop GI cancers from returning?
NCT ID NCT04111172
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing an experimental vaccine called Ad5.F35-hGCC-PADRE in adults who have had surgery and standard treatment for gastrointestinal cancers, including pancreatic, colorectal, esophageal, gastric, and small bowel adenocarcinomas. The trial aims to find a safe dose and see whether the vaccine triggers an immune response against a protein called GCC that is found on these cancer cells. Participants receive the vaccine as an injection, and researchers measure immune responses and monitor side effects. The study also explores whether the vaccine can clear tiny amounts of remaining cancer DNA in the blood of some colon cancer patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental vaccine called Ad5.F35-hGCC-PADRE that trains the immune system to target a protein found on gastrointestinal cancer cells
- What this could lead to
- If it works, this vaccine could offer a way to help the immune system keep gastrointestinal cancers from coming back after surgery and standard treatment.
- What could go wrong
- This is a small, early-stage trial. The vaccine may not trigger a strong enough immune response, may cause side effects, or may not prevent relapse. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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48 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 functions, test results should not be worse than grade 1 levels of abnormalities defined by Common Terminology Criteria for Adverse Events (CTCAE), National Cancer Institute (NCI) version 5 issued by the United States (US) Department of Health and Human Services * For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormonal implants) or abstinence must be used throughout the study period and for 28 days after their final vaccine administration (a barrier method of contraception must be employed by all subjects \[male and female\], regardless of other methods unless abstinent). A negative serum or urine pregnancy test is required as part of screening. Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/ml * Be willing to comply with all the study procedures * All subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: * Have a known history or evidence of residual disease after definitive surgery * Have a known metastasis in the brain or central nervous system * Prior receipt of immunotherapy or experimental medications after completion of standard adjuvant therapy * Have a history of splenectomy * Have a history of distal pancreatectomy * Concurrent use of systemic steroids or immunosuppressive drugs (use of topical or inhaled steroids will be allowed) * Have any immunodeficiency disease or immunocompromised state (e.g., use of immunosuppressive agents, chemotherapy or radiation therapy within four weeks of study treatment) * Have active autoimmune disease or history of autoimmune disease or a transplant recipient requiring systemic steroids or other immunosuppressive treatment * Have received a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (subjects who are hepatitis C positive may be enrolled if they are confirmed with negative viral load at screening) * Other malignancy within last 5 years except curatively treated non-melanomatous skin cancer and curatively treated carcinoma in situ of the uterine cervix, or early-stage (stage A or B1) prostate cancer * Have a history of inflammatory bowel disease * Have a history of serious reaction to adenovirus * Have an intercurrent illness that is either life-threatening or of clinical importance such that it might limit study compliance (such illnesses include, but are not limited to, ongoing or active infection, metabolic or neurologic disease, peripheral vascular disease, or psychiatric illness) * Have insufficient peripheral venous access to permit completion of the study phlebotomy regimen * Consumes greater than three glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\]) per day and cannot refrain from alcohol for the duration of the trial * Has a history of use of illicit drugs (e.g., opioids, cocaine, amphetamines, hallucinogens, etc.) that could potentially interfere with adherence to study procedures or requirements * Be a woman who is pregnant or breastfeeding * Have an unhealed surgical wound * Have had major surgery or significant traumatic injury occurring within 28 days before treatment or anticipated surgery or procedure requiring general anesthesia during the study participation (including four weeks after last dose of vaccine)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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- Can berry compounds tame inflammation during colorectal cancer care?