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AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

ConditionPancreatic Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years；

Eastern Cooperative Oncology Group (ECOG) score of 0-1;

Pancreatic cancer confirmed by histology or cytology;

Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;

Disqualifiers

Have received systematic anti-tumor treatment.

Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment).

Active bacterial or fungal infection (> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).

Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group.

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Drug

    Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks

  • Gemcitabine

    Drug

    Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks

  • Nab paclitaxel

    Drug

    Nab paclitaxel 125 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.

  • SBRT

    Other intervention

    SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions

Treatment groups

108 Participants
are divided into 1 treatment group
Group A: Concurrent radiochemotherapy combined with immunotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

ORR

RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1

Time frame
2 years
2

R0 resection rate

R0 resection rate

Time frame
2 years

Secondary outcomes

1

os

OS is defined as the time from randomization to death due to any cause.

Time frame
3 years
2

pfs

PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.

Time frame
3 years
3

dcr

DCR including CR, PR, and SD

Time frame
3 years
4

Adverse Events

Adverse event (AE)、Serious adverse event (SAE)

Time frame
3 years

Other outcomes

Sponsors and contacts

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Fudan University

Collaborator

Shanghai Changzheng Hospital

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator

Xuzhou Central Hospital

Collaborator

Source ClinicalTrials.gov

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