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

ConditionsPancreatic Cancer, Stage IBPancreatic Cancer, Stage IIAPancreatic Cancer, Stage IIBPancreatic Cancer Stage III
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • sintilimab

    Drug

    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.

  • nab-paclitaxel

    Drug

    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.

  • gemcitabine

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: sintilimab + nab-paclitaxel + gemcitabineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

2-year overall survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

To evaluate the overall survival of patients with resectable and borderline resectable pancreatic cancer treated with the combination of sintilimab and gemcitabine plus nab-paclitaxel. Outpatient visit, phone interview

Time frame
From date of enrollment to the date of death for any cause, assessed 2 months during therapy and 3 months thereafter up to 24 months

Secondary outcomes

1

Overall survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

To evaluate the overall survival of patients treated with this regimen. Outpatient visit, phone interview

Time frame
From date of enrollment until the date of death from any cause, assessed one month during therapy and 3 months thereafter up to 24 months
2

Event-free survival after the application of sintilimab and gemcitabine plus nab-paclitaxel

To evaluate the event-free survival of patients treated with this regimen. Outpatient visit, phone interview

Time frame
From date of enrollment until the date of death from any cause, assessed one month during therapy and 3 months thereafter up to 24 months
3

Objective response rate and disease control rate after finishing the course of the treatment of sintilimab and gemcitabine plus nab-paclitaxel

To evaluate the objective response rate and disease control rate of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview

Time frame
One month during therapy and 3 months thereafter up to 24 months
4

Recurrence-free survival after finishing the course of the treatment of sintilimab and gemcitabine plus nab-paclitaxel and curative resection

To evaluate the recurrence-free survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview

Time frame
One month during therapy and 3 months thereafter up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Fudan University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: