Chemotherapy + TheraBionic for Pancreatic Cancer

Overseen By Ravi Paluri, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: THERABIONIC INC.

Must not be taking: Calcium channel blockers

Disqualifiers: Brain metastases, Recent malignancy, Infections, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for pancreatic cancer by combining standard chemotherapy with a device called TheraBionic. The goal is to assess how effectively the combination of chemotherapy drugs gemcitabine (Gemzar) and nab-paclitaxel (Abraxane), along with the TheraBionic device, manages the disease and its side effects. It targets individuals recently diagnosed with metastatic pancreatic cancer, meaning the cancer has spread to other parts of the body and remains untreated. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking calcium channel blockers (medications that affect heart and blood pressure) like amlodipine or nifedipine before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What prior data suggests that the TheraBionic device is safe for use with chemotherapy?

Research shows that combining gemcitabine and nab-paclitaxel, a common treatment for pancreatic cancer, is generally safe. Most patients experience manageable side effects such as tiredness, nausea, and hair loss. Studies have found that adding the TheraBionic device, which uses radio waves, to this treatment is also well-tolerated. Early results suggest that this addition may improve patient outcomes, although further research is needed for confirmation. Overall, current evidence indicates that the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for pancreatic cancer because it combines standard chemotherapy (gemcitabine and nab-paclitaxel) with a novel approach: the TheraBionic device. This device uses amplitude-modulated radiofrequency electromagnetic fields, which is a unique method of potentially enhancing the effectiveness of chemotherapy. Unlike current options that only rely on drugs, this combination targets cancer cells through two different mechanisms, offering hope for improved outcomes in this challenging condition.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research shows that the combination of gemcitabine and nab-paclitaxel, known as GEM-ABR, holds promise for treating pancreatic cancer. Studies have found that patients using this combination live an average of 8.5 months, compared to 6.7 months with gemcitabine alone. This combination also helps control the disease by preventing the cancer from spreading. In this trial, researchers are testing the TheraBionic device, which uses radio waves, in combination with GEM-ABR to determine if it can enhance these results. While the effects of the TheraBionic device are still under investigation, GEM-ABR is already considered effective for pancreatic cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Ravi K Paluri, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed, untreated metastatic pancreatic adenocarcinoma. They should be in good physical condition (ECOG 0-1), have measurable tumors, and agree to use two forms of contraception if applicable. Exclusions include prior chemotherapy for metastasis, enrollment in other trials, certain heart medications, uncontrolled illnesses, recent major surgery, brain metastases or a history of severe allergies to the drugs being tested.

Inclusion Criteria

I agree to use two forms of birth control during and up to 6 months after the study.

Your blood counts, liver and kidney functions need to be within certain limits. If they are too low, you may need a blood transfusion to qualify.

I have a new diagnosis of metastatic pancreatic cancer confirmed by biopsy.

Exclusion Criteria

You have had allergic reactions to drugs similar to gemcitabine and nab-paclitaxel.

I haven't had chemotherapy for advanced cancer or specific drugs in the last 6 months, but FOLFIRINOX is okay.

Unable to comply with study procedures or anticipating a situation that would result in a treatment break for 14 or more consecutive days after the start of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine and nab-paclitaxel therapy in combination with amplitude-modulated radiofrequency electromagnetic fields using the TheraBionic device

6 months

Regular visits for chemotherapy administration and device usage

Follow-up

Participants are monitored for safety, progression-free survival, and overall survival

Up to 1 year

Periodic visits for CT or MRI scans and clinical assessments

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab paclitaxel
• TheraBionic

Trial Overview

The study examines the effects of standard chemotherapy (gemcitabine and nab-paclitaxel) combined with TheraBionic device treatment on patients with advanced pancreatic cancer. The goal is to assess how this combination influences the disease compared to traditional treatments alone.

How Is the Trial Designed?

Group I: GEM-ABR [Gemcitabine - Abraxane (nab-Paclitaxel)] with TheraBionic device Experimental Treatment 3 Interventions

Metastatic pancreatic cancer patients will be treated with amplitude-modulated radiofrequency electromagnetic fields using TheraBionic device in combination with standard chemotherapy, gemcitabine- nab-paclitaxel. amplitude-modulated radiofrequency electromagnetic fields will be delivered by the TheraBionic device.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

THERABIONIC INC.

Lead Sponsor

Trials

3

Recruited

210+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Therabionics

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 670 Veterans with advanced pancreatic cancer, the combination of gemcitabine and nab-paclitaxel (Gem/NabP) showed similar overall survival rates compared to FOLFIRINOX, indicating that Gem/NabP is noninferior to FOLFIRINOX for this patient population.

The study utilized a novel tumor growth formula based on CA19-9 biomarker data, suggesting that this approach could be valuable for monitoring treatment responses and predicting outcomes in pancreatic cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in Veterans. Sigel, K., Zhou, M., Park, YA., et al.[2023]

Itacitinib, a selective JAK1 inhibitor, combined with nab-paclitaxel and gemcitabine, showed an acceptable safety profile and clinical activity in patients with advanced solid tumors, including pancreatic cancer, with a 24% overall response rate across various doses.

The study indicated that while itacitinib was tolerated at lower doses, treatment-related toxicities such as neutropenia and fatigue were common, leading to dose adjustments; however, the study was terminated early due to negative results from a related phase III trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Beatty, GL., Shahda, S., Beck, T., et al.[2022]

In a study involving 866 patients with resected pancreatic ductal adenocarcinoma, the combination of nab-paclitaxel and gemcitabine showed a significant improvement in overall survival (OS) compared to gemcitabine alone, with a median OS of 41.8 months versus 37.7 months, respectively.

Although the primary endpoint of disease-free survival (DFS) was not significantly improved with nab-paclitaxel + gemcitabine, the treatment was associated with a higher incidence of grade ≥ 3 adverse events (86% vs. 68% for gemcitabine), indicating a need for careful consideration of safety alongside efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial. Tempero, MA., Pelzer, U., O'Reilly, EM., et al.[2023]

A study of 5465 patients with advanced pancreatic cancer in Ontario showed that the introduction of new chemotherapy regimens, GEMNAB and FOLFIRINOX, significantly improved overall survival rates over time, with median survival increasing from 5.6 months to 7.6 months between 2008 and 2018.

FOLFIRINOX was found to provide better overall survival compared to GEMNAB, particularly in younger and healthier patients, while GEMNAB still showed improved survival compared to the older standard treatment, gemcitabine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. Raphael, MJ., Raskin, W., Habbous, S., et al.[2023]

In a phase I trial involving 50 patients with advanced pancreatic cancer, the combination of nivolumab, nab-paclitaxel, and gemcitabine showed a manageable safety profile, with 48 patients experiencing grade 3/4 treatment-emergent adverse events, but only one dose-limiting toxicity reported.

The treatment resulted in a median overall survival of 9.9 months and an overall response rate of 18%, indicating limited efficacy, which led to the conclusion that further investigation of this combination is not supported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer. Wainberg, ZA., Hochster, HS., Kim, EJ., et al.[2022]

In a study of 58 patients with resectable metastatic pancreatic cancer treated with gemcitabine and docetaxel, the median overall survival was 52 months, with a 5-year survival rate of 49%, indicating a favorable outcome for this treatment approach.

The study found that while 52% of patients experienced significant toxicity (grade 3 or 4), the majority completed their treatment regimen, and the use of chemoradiation after gem/tax was positively associated with improved survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and Taxane Adjuvant Therapy with Chemoradiation in Resected Pancreatic Cancer: A Novel Strategy for Improved Survival? Kanji, ZS., Edwards, AM., Mandelson, MT., et al.[2022]

In a study of 80 Italian patients with metastatic pancreatic cancer, treatment with nab-paclitaxel in combination with gemcitabine resulted in a median overall survival of 8 months and a median progression-free survival of 5 months, indicating its efficacy.

Nab-paclitaxel was well-tolerated and led to significant pain relief, with reductions in the tumor marker CA 19-9 correlating positively with overall survival, suggesting it may be a useful predictor of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of nab-paclitaxel in patients with metastatic pancreatic cancer. De Luca, R., Blasi, L., Alù, M., et al.[2022]

Recent treatment regimens for advanced pancreatic cancer, including gemcitabine, FOLFIRINOX, and nab-paclitaxel, have shown varying levels of efficacy, highlighting the importance of understanding their unique safety profiles.

Nurses play a crucial role in patient education and symptom management, as each treatment regimen has different adverse events that need to be identified and managed effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nursing Implications of Chemotherapy Agents and Their Associated Side Effects in Patients With Pancreatic Cancer. Hronek, JW., Reed, M.[2017]

The neoadjuvant therapy combining nab-paclitaxel and gemcitabine for patients with borderline resectable pancreatic carcinoma was found to be safe and feasible, with high rates of adverse events primarily due to expected neutropenia.

The treatment resulted in an 80% resection rate and a 70% R0 resection rate, indicating that a significant proportion of patients could undergo successful surgical intervention after therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer. Okada, KI., Hirono, S., Kawai, M., et al.[2022]

The combination of nab-paclitaxel, gemcitabine, and capecitabine was found to be well tolerated in a phase I study with 15 patients, establishing a maximum-tolerated dose (MTD) but showing only modest antitumor activity in metastatic pancreatic cancer.

Despite the regimen being generally safe, with a low incidence of severe hematologic toxicities, only 14.3% of patients had a partial response, indicating that optimizing dose intensity may be crucial for improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of nab-paclitaxel, gemcitabine, and capecitabine for metastatic pancreatic cancer. Ko, AH., Truong, TG., Kantoff, E., et al.[2022]

In a study of patients with resected pancreatic ductal adenocarcinoma (PDAC), adjuvant chemotherapy with nab-paclitaxel plus gemcitabine (AG) significantly improved median disease-free survival (15.8 months) and overall survival (28.3 months) compared to gemcitabine alone (12.2 months and 20.6 months, respectively).

While AG showed better survival outcomes, it also led to a higher incidence of sensory neuropathy (53.3% in AG vs. 23.3% in GEM), indicating a trade-off between efficacy and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant nab-paclitaxel plus gemcitabine vs gemcitabine alone for resected pancreatic ductal adenocarcinoma: A single center experience in China. Yin, ZZ., Zhao, ZM., Tang, WB., et al.[2020]

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