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Immunotherapy

PCX-12 + Radiotherapy for Pancreatic Cancer

Phase 1

Waitlist Available

Led By Haoming Qiu

Research Sponsored by Haoming (Carl) Qiu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-2

Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas initially staged as locally advanced by NCCN criteria

Must not have

Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure

History of past malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if a new treatment that combines radiation therapy with PCX12 is safe and well-tolerated.

Who is the study for?

This trial is for individuals with locally advanced pancreatic adenocarcinoma. Specific eligibility details are not provided, but typically participants should meet certain health standards and may be required to have a particular stage of cancer.

What is being tested?

The study is testing the safety and tolerability of combining Stereotactic Body Radiotherapy (SBRT) with an immunotherapy drug called PCX12, administered directly into the tumor in patients with pancreatic cancer.

What are the potential side effects?

While specific side effects are not listed, generally SBRT can cause fatigue, skin reactions, and gastrointestinal symptoms; immunotherapies like PCX12 might lead to immune-related inflammation or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My pancreatic cancer is advanced but has not spread far.

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I finished my first round of chemotherapy and my cancer hasn't spread or gotten worse.

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My tumor is still visible on a CT scan after chemotherapy.

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My tumor can be targeted with a special type of radiation and can be injected with medicine using an ultrasound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo SBRT, endoscopic ultrasound, or IL-12 injections.

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I have had cancer before.

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My cancer has spread or worsened after initial treatment.

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I have had surgery or radiation for pancreatic cancer before.

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My scans show no signs of cancer after my first chemotherapy.

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I do not have a severe illness that would shorten my life to under 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

Maximum tolerable dose [Safety and Tolerability]

Secondary study objectives

Change in biomarkers of innate and adaptive immunity

Rate of radiographic response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PCX-12Experimental Treatment1 Intervention

PCX-12 is an experimental immunotherapy drug that is injected into the pancreatic cancer one time in attempt to stimulate the patient's immune system to fight the cancer.

0 / 11Eligibility criteria met