Clinical trial · Interventional
S-1, Gemcitabine and Erlotinib for Advanced Pancreatic Cancer
A Phase II Study of S-1 in Combination With Gemcitabine and Erlotinib in Patients With Advanced or Metastatic Pancreatic Cancer
NCT01693419CI-TRIAL-00029226completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression, KRAS mutation, and BRAF mutation as predictive or prognostic markers
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 |
|---|---|---|---|
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GES (Gemcitabine, Erlotinib, S-1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GES (Gemcitabine, Erlotinib, S-1)
- description
- Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14
- interventionNames
- Drug: GES (Gemcitabine, Erlotinib, S-1)
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1.5 years
- description
- Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
Secondary outcomes (4)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system) * Measurable or evaluable disease by RECIST criteria 1.1 * Minimum age of 18 years * ECOG Performance status 0-1 * Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy. * More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field) * Adequate organ functions * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital. Exclusion Criteria: * Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy. * Patients with CNS metastases * Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding * Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix * Known history of cerebral or leptomeningeal metastases or neurologic disease
References
Publications (0)
Data not yet available
No reference posted for this study.