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

NCT05562297 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-22

No results posted yet for this study

Summary

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

Conditions

  • Pancreatic Cancer, Stage IB
  • Pancreatic Cancer, Stage IIA
  • Pancreatic Cancer, Stage IIB
  • Pancreatic Cancer Stage III

Interventions

DRUG

sintilimab

Patients firstly receive sintilimab 200 mg (iv, 30 minutes) on day 1 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 3 circles in the absence of disease recurrence or unacceptable toxicity.

DRUG

nab-paclitaxel

Patients firstly receive nab-paclitaxel 125 mg/m\^2 (iv, 30 minutes) on days 1, and 8 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 3 circles in the absence of disease recurrence or unacceptable toxicity.

DRUG

gemcitabine

Patients secondly receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, and 8 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 3 circles in the absence of disease recurrence or unacceptable toxicity.

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Liang Liu, MD, PhD · Shanghai Zhongshan Hospital

  • Wen-hui Lou, MD, PhD · Shanghai Zhongshan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2027-10-01
Completion
2028-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562297 on ClinicalTrials.gov