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A prospective multicenter phase II clinical study for neoadjuvant therapy of gemcitabine combined with albumin paclitaxel for resectable pancreatic cancer

A prospective multicenter phase II clinical study for neoadjuvant therapy of gemcitabine combined with albumin paclitaxel for resectable pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021840
Enrollment
Unknown
Registered
2019-03-12
Start date
2019-03-25
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Case series:nab-paclitaxel plus gemcitabine

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients must have histologically confirmed borderline resectable pancreatic adenocarcinoma follow 2018 V1 NCCN; 2. Patients must have cytologically or histologically confirmed pancreatic ductal adenocarcinoma; 3. Treatment naive; 4. Aged 18 to 80 years; 5. The expected survival = 3 months; 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 7. There was at least one measurable tumor lesion; 8. Absolute neutrophil count (ANC) = 1.5 × 10^9/L; Platelets (PLT) = 80 × 10^9/L; Hemoglobin (Hgb) = 80 g/L Creatinine (CRE) = 1.5 ×institutional upper limit of normal (ULN)Total bilirubin (TBIL) = 2.5 ×ULN; Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) /Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ Alkaline phosphatase(ALP)= 2.5 ×ULN; 9. Signed informed content obtained prior to treatment.

Exclusion criteria

Exclusion criteria: 1. History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine; 2. Patients with Coagulation dysfunction or active internal hemorrhage; 3. Active second primary malignancy or history of second primary malignancy within the last 5 years. However, if a radical treatment has been performed on a carcinoma in situ or intramucosal carcinoma, the disease-free interval does not matter; 4. Patients with interstitial lung disease or pulmonary fibrosis; 5. Patients with uncontrolled pleural effusion or ascites; 6. Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, history of myocardial infarction within the last 3 months; 7. Patients who are pregnant or may be pregnant or nursing; 8. Patients must have histologically confirmed resectable or unresectable pancreatic adenocarcinoma follow 2018 V1 NCCN; 9. Any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.

Design outcomes

Primary

MeasureTime frame
OS;

Countries

China

Contacts

Public ContactDan Cao

West China Hospital, SIchuan University

caodan316@163.com+86 18980605963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026