A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma (NCT04111172) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: 13 weeks
2
Antigen-specific T-cell response to guanylyl cyclase C (GCC)