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Phase 2 Trial of preoperative treatment with Nab-paclitaxel Plus S-1 in Patients With borderline resectable Pancreatic Cancer

Phase 2 Trial of preoperative treatment with Nab-paclitaxel Plus S-1 in Patients With borderline resectable Pancreatic Cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016899
Enrollment
Unknown
Registered
2018-07-01
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-07-09

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 S-1 as neoadjuvant therapy

Sponsors

Department of Hepato-pancreato-biliary surgical oncology, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old male and female; 2. Preoperative diagnosis of pancreatic ductal adenocarcinoma was confirmed based on clinical symptoms, imaging examinations, tumor markers and other auxiliary examinations or biopsy results; 3. According to the NCCN guideline (2017 V3), the inclusion PDAC is borderline resectable pancreatic cancer via preoperative imaging examinations. Arterial status: Pancreatic head or uncinate process: solid tumor contact with common hepatic artery (CHA) without extension to celiac axis or hepatic artery bifurcation allowing for safe and complete resection and reconstruction; solid tumor contact with the SMA of =180 degree; solid tumor contact with variant arterial anatomy (ex: accessory right hepatic artery, replaced right hepatic artery, replaced CHA and the origin of replaced or accessory artery) and the presence and degree of tumor contact should be noted if present. Pancreatic body/tail: solid tumor contact with the celiac axis (CA) of =180 degree; solid tumor contact with the CA of >180 degree without involvement of the aorta and with intact and uninvolved gastroduodenal artery. Venous status: solid tumor contact with the SMV or PV of >180 degree, contact of =180 degree with contour irregularity of the vein or thrombosis of the vein but with suitable vessel proximal and distal to the site of involvement allowing for safe and complete resection and vein reconstruction; solid tumor contact with the inferior vena cava(IVC); 4. Participate in the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. With other system malignant tumor; 2. Accept any form of anti-tumor treatment 5 weeks before grouping randomly, including intervention, ablation, radiotherapy, chemotherapy and molecular targeted therapy, etc.; 3. Using any study drug in other clinical trials 5 weeks before grouping randomly; 4. With any central nervous system disease, mental disease, unstable angina, severe congestive heart failure, arrhythmia or other serious diseases which cannot be control; 5. With allergy history of clinical trial drugs or similar structure drugs; 6. Lactating or pregnant; 7. Any situation which could damage patient safety or the integrity of the data,including severe medical risk factors, medical conditions, and laboratory abnormalities; 8. immunosuppressive patients; 9. The researchers considered it inappropriate to participate in the experiment; 10. Patients are unwilling or unable to comply with the program, or loss to follow-up for more than 1 course during treatment. such as HIV positive.

Design outcomes

Primary

MeasureTime frame
R0 resection rate;Disease-free survival, DFS;

Secondary

MeasureTime frame
Overall survival;colligation condition during operation;safety profile;Quality of Life Assessment;

Countries

China

Contacts

Public ContactLiu Rong

Chinese PLA General Hospital

liurong301@126.com+86 010-66937591

Outcome results

None listed

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