Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

The purpose of this research is to investigate the activity and safety of the combination of gemcitabine plus nab-paclitaxel and sintilimab as neoadjuvant therapy in treating patients with resectable and borderline resectable pancreatic cancer.

The drugs involved in this study are:

* Sintilimab * Nab-paclitaxel * Gemcitabine

Eligibility criteria

Qualifiers

Signed informed content obtained prior to treatment

Age ≥ 18 years and ≤ 75 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patients must have imaging evaluations to confirm that their pancreatic adenocarcinoma is resectable and borderline resectable. Patients must have histologically confirmed pancreatic adenocarcinoma, too.

Disqualifiers

The diameter of the resectable tumor is ≤ 2 cm in imaging evaluation

Associated with other malignant tumors

Patients receiving anti-tumor treatment before neoadjuvant therapy, including systemic chemotherapy, interventional chemotherapy, high-energy focused ultrasound, radiotherapy, immunotherapy, molecular targeted therapy, and anti-tumor Chinese medicine therapy

Use of any other investigational agents

Trial design

Treatments tested in this trial

  • sintilimab
  • nab-paclitaxel
  • gemcitabine

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Zhongshan Hospital

Lead sponsor

Fudan University

Collaborator