Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

Cancer Advances Inc.394 enrolled

Overview

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

394

Conditions

Pancreatic Cancer

Interventions

G17DT ImmunogenBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection * Life expectancy of at least 3 months * Functional status by Karnofsky Index of at least 70 Exclusion criteria: * Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy * Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease * Immunodeficiency * Bone marrow transplant within past year * Brain metastasis

Outcomes

Primary Outcomes

Survival

Time frame: Up to 12 months

Secondary Outcomes

Number of Participants with Serious and Non-Serious Adverse Events

Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-existing illnesses, were assessed at each visit.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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