Clinical trial · Interventional
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma
Prospective, Randomized, Controlled, Double-Blind, Multi-National, Multi-Center Study of G17DT Immunogen in Combination With Gemcitabine Versus Placebo in Combination With Gemcitabine in Previously Untreated Subjects With Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection, or Metastatic (Stage IV) Adenocarcinoma of the Pancreas (Protocol No. PC4)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G17DT Immunogen | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Placebo (immunogen vehicle) combined with gemcitabine.
- type
- EXPERIMENTAL
- label
- A
- description
- 500 µg G17DT immunogen combined with gemcitabine.
- interventionNames
- Biological: G17DT Immunogen
Primary outcomes (1)
- measure
- Survival
- timeFrame
- Up to 12 months
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available