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Immunotherapy

PCX-12 for Pancreatic Adenocarcinoma

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Maximum tolerable dose [Safety and Tolerability]

Secondary outcome measures

Change in biomarkers of innate and adaptive immunity

Rate of radiographic response

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Haoming (Carl) QiuLead Sponsor

Haoming QiuPrincipal InvestigatorUniversity of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"According to the information provided on clinicaltrials.gov, this particular trial is currently not actively recruiting participants. The trial was initially posted on October 31, 2024 and last updated on January 19, 2024. However, it's worth noting that there are presently 797 other trials enrolling participants at this time."

Answered by AI

Has the Food and Drug Administration granted its approval for the use of PCX-12?

"As this is a Phase 1 trial, there is limited data available to support the safety and efficacy of PCX-12. Thus, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)

Haoming (Carl) Qiu 2024. "Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06217666.

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