Clinical trial · Interventional
A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )
A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
NCT03825328CI-TRIAL-00036850unknownPhase 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 is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer. This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy
- description
- Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
- interventionNames
- Drug: Albumin-bound paclitaxel
- Drug: S-1
- Drug: Oxaliplatin
- Drug: Gemcitabine
Primary outcomes (2)
- measure
- PFS
- timeFrame
- from the first drug administration up to 6 months
- description
- progression-free survival
- measure
- OS
- timeFrame
- from the first drug administration up to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily participate in the trial and sign the informed consent form 2. 18 years old \<age \<75 years old 3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria 4. ECOG score 0-1 5. Life expectancy \> 3 months 6. There must be a CT or MRI examination within a week 7. at least one lesion that can be measured by the RECIST v1.1 standard 8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months) 9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area) Exclusion Criteria: 1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures; 2. Severe active infections requiring intravenous antibiotic treatment during enrollment; 3. those who are allergic to the test drug; 4. There is ≥2 neuropathy (CTCAE 4.0); 5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction; 6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack; 7. Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled; 8. Patients who are unable to follow the protocol or who are unable to follow up;
References
Publications (0)
Data not yet available
No reference posted for this study.