PCX-12 + Radiotherapy for Pancreatic Cancer

Overseen By Haoming Qiu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Haoming (Carl) Qiu

Disqualifiers: Metastatic disease, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment PCX-12 + Radiotherapy for Pancreatic Cancer?

Research shows that combining radiotherapy with chemotherapy can improve outcomes for pancreatic cancer patients by better controlling the disease locally. Proton beam radiotherapy, a type of radiotherapy, can deliver high doses to the tumor while protecting nearby organs, potentially reducing side effects and improving treatment effectiveness. ^{1 2 3 4 5}

What safety data exists for PCX-12 + Radiotherapy in pancreatic cancer treatment?

The studies reviewed focus on radiotherapy for pancreatic cancer, highlighting that different types of radiation therapy can have varying levels of gastrointestinal side effects like nausea, vomiting, and diarrhea. However, specific safety data for PCX-12 combined with radiotherapy is not provided in these studies, so further research is needed to understand its safety profile. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.

Research Team

Haoming Qiu

Principal Investigator

University of Rochester

Eligibility Criteria

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.

Inclusion Criteria

Anticipated life expectancy ≥ 12 weeks

I can take care of myself and perform daily activities.

My pancreatic cancer is advanced but has not spread far.

Exclusion Criteria

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

I have had cancer before.

My cancer has spread or worsened after initial treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo standard of care radiation therapy

4 weeks

Treatment

Participants receive PCX12 immunotherapy with escalating doses from 200 ng/kg to 800 ng/kg

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• PCX-12

Trial Overview 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.

Participant Groups

Group I: PCX-12 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Haoming (Carl) Qiu

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

In a meta-analysis of 830 patients with locally advanced unresectable pancreatic cancer, adding radiotherapy to chemotherapy did not improve overall survival or progression-free survival in randomized controlled trials, and it was associated with increased severe gastrointestinal adverse events.

Observational studies suggested a potential benefit of radiotherapy on survival outcomes, but these results may be influenced by differences in patient characteristics, highlighting the need for further research to identify which patients might truly benefit from radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy versus chemotherapy for locally advanced unresectable pancreatic cancer: A systematic review and meta-analysis. Ng, IW., Soon, YY., Chen, D., et al.[2019]

Proton radiotherapy offers a promising approach for treating pancreatic carcinoma by delivering high doses of radiation directly to tumors while minimizing damage to surrounding healthy organs, which can reduce treatment toxicity.

Combining proton radiotherapy with improved chemotherapy regimens is essential for enhancing local-regional control of pancreatic cancer, potentially leading to better overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam radiotherapy for pancreas cancer. Rutenberg, MS., Nichols, RC.[2020]

Concurrent chemotherapy and radiotherapy for pancreatic adenocarcinoma can lead to predictable acute toxicities that vary based on the intensity of the treatment and the specifics of the radiotherapy, highlighting the importance of careful management.

Proactive planning and management of both surgical complications and treatment toxicities are crucial to prevent unplanned treatment interruptions and ensure patients can complete their therapy effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care considerations during concurrent chemoradiotherapy for pancreatic adenocarcinoma: lessons learned from clinical experience. Wang-Gillam, A., Abrams, RA., Posner, MC., et al.[2013]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy versus chemotherapy for locally advanced unresectable pancreatic cancer: A systematic review and meta-analysis. [2019]

2. China pubmed.ncbi.nlm.nih.gov

Proton beam radiotherapy for pancreas cancer. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Neoadjuvant chemoradiation for non-metastatic pancreatic cancer increases margin-negative and node-negative rates at resection. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Identification of Key Genes Mutations Associated With the Radiosensitivity by Whole Exome Sequencing in Pancreatic Cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant gemcitabine, docetaxel, and capecitabine followed by gemcitabine and capecitabine/radiation therapy and surgery in locally advanced, unresectable pancreatic adenocarcinoma. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Volume and Radiobiological Model-Based Comparative Evaluation of the Gastrointestinal Toxicity Risk of Photon and Proton Irradiation Plans in Localized Pancreatic Cancer Without Distant Metastasis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Supportive care considerations during concurrent chemoradiotherapy for pancreatic adenocarcinoma: lessons learned from clinical experience. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

A multicenter phase II trial of S-1 with concurrent radiation therapy for locally advanced pancreatic cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy reduces gastrointestinal toxicity in locally advanced pancreas cancer. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

SBRT in pancreatic cancer: what is the therapeutic window? [2022]