IMD10 + Chemotherapy for Pancreatic Cancer

Not yet recruiting at 5 trial locations
JJ
Overseen ByJeongmin Jang, Clinical Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: IMGT Co., Ltd.
Must be taking: Chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using focused ultrasound, called IMD10, combined with standard chemotherapy to help people with pancreatic cancer that is difficult to remove surgically. The goal is to assess the safety and effectiveness of this approach for those with borderline resectable or locally advanced pancreatic cancer. Participants must have a diagnosis of pancreatic cancer and at least one measurable tumor. The study includes two groups: one will receive the new ultrasound treatment with chemotherapy, while the other will receive chemotherapy alone. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in pancreatic cancer treatment.

Will I have to stop taking my current medications?

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

What prior data suggests that IMD10 is safe for treating pancreatic cancer?

Research shows that IMD10, when combined with chemotherapy, is under study for safety in treating pancreatic cancer. Previous studies have found that IMD10, a type of focused ultrasound treatment, is generally well-tolerated. In one study, combining IMD10 with chemotherapy did not cause major safety issues. However, some patients experienced mild side effects like tiredness and discomfort, which are common with any cancer treatment.

This trial aims to gather more detailed safety information. While researchers continue to test IMD10, current evidence suggests it is relatively safe when used with standard chemotherapy drugs. Always consult a healthcare provider before joining a trial to understand its implications for your health.12345

Why are researchers excited about this trial's treatment?

IMD10 is unique because it is combined with a standard chemotherapy regimen to potentially enhance its effectiveness against pancreatic cancer. Unlike traditional treatments that rely solely on chemotherapy agents like irinotecan hydrochloride and oxaliplatin, IMD10 introduces a new element that might improve patient outcomes. Researchers are excited about IMD10 because it could work synergistically with chemotherapy, offering a new mechanism that may boost the body's response to treatment and provide better results for patients facing this challenging cancer.

What evidence suggests that IMD10 with chemotherapy could be effective for pancreatic cancer?

Research has shown that IMD10, a type of focused ultrasound treatment, might help reduce the size of pancreatic tumors. One study found that tumors in seven out of nine patients shrank by more than 15% after receiving this treatment. This is encouraging because pancreatic cancer is difficult to treat. In this trial, participants in the experimental group will receive IMD10 alongside a chemotherapy plan that includes drugs like irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU), and leucovorin. This combination aims to enhance the effectiveness of current treatments. These findings suggest that IMD10 could be a helpful addition to chemotherapy for treating pancreatic cancer.12367

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with borderline resectable or locally advanced pancreatic cancer, confirmed by pathology. Participants must have a measurable lesion, be in good physical condition (ECOG status 0 or 1), and have certain blood and organ function levels. They should not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential.

Inclusion Criteria

I am between 18 and 85 years old.
My diagnosis of pancreatic cancer is confirmed by lab tests on tissue or fluid samples.
My pancreatic cancer is classified as borderline resectable or locally advanced.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a chemotherapy regimen with or without IMD10 (focused ultrasound)

12 weeks
Weekly visits for chemotherapy administration

Follow-up

Participants are monitored for safety and survival until the end of the study

Until end of study

What Are the Treatments Tested in This Trial?

Interventions

  • IMD10

Trial Overview

The trial is testing the safety and effectiveness of IMD10 (focused ultrasound) combined with a chemotherapy regimen including irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU), and leucovorin in treating pancreatic cancer that's on the verge of being operable or has spread locally.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental groupExperimental Treatment2 Interventions
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

IMGT Co., Ltd.

Lead Sponsor

Citations

Study Details | NCT07325214 | Chemotherapy With or ...

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