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Pancreatectomy with combined targeted therapy and neoadjuvant chemotherapy in locally advanced pancreatic cancer

Pancreatectomy with combined targeted therapy and neoadjuvant chemotherapy in locally advanced pancreatic cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084464
Enrollment
Unknown
Registered
2024-05-16
Start date
2024-05-16
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

Experimental group:Ninituzumab + Gemcitabine plus albumin-bound purpurinol+Radical resection

Sponsors

West China Hospital , Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: . Age range: 18 to 75 years old. 2. Histopathologically or cytologically confirmed pancreatic ductal adenocarcinoma. 3. Initial imaging evaluation according to the NCCN Guidelines 2022 for locally advanced, unresectable pancreatic cancer. 4. Eastern Cooperative Oncology Group (ECOG) performance status score =2. 5. Adequate liver, cardiac, renal, and bone marrow function (absolute neutrophil count >1500/mm3, platelet count >150,000/µl, creatinine clearance >60 ml/min). 6. Obtained informed consent from both the patient and their family.

Exclusion criteria

Exclusion criteria: 1. Non-locally progressive tumors with definite metastasis (M1) are present. 2. Individuals with serious or uncontrolled medical conditions and those who are infected. 3. Patients requiring management of seizures, such as steroid or antiepileptic therapy. 4. Those unable to tolerate neoadjuvant therapy and nituzumab. 5. Any unstable conditions or factors that may compromise patient safety and compliance. 6. Participants who have previously undergone chemotherapy, radiotherapy, or other antitumor therapies before the trial. 7. Pregnant women, those at risk of becoming pregnant, and breastfeeding individuals.

Design outcomes

Primary

MeasureTime frame
The radical resection rate (R0);Conversion Rate;Objective response rate (ORR);Tumor regression Scale (TRG);

Secondary

MeasureTime frame
Progression-free survival (PFS);Disease-free survival (DFS);Overall survival (OS);Complication rate;

Countries

China

Contacts

Public ContactYi Zhang

Department of Pancreatic Surgery, West China Hospital, Sichuan University

zhangyide520@163.com+86 189 8060 6407

Outcome results

None listed

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