What side effects are associated with this type of intervention?

Common treatments for Gastroesophageal Junction Adenocarcinoma, such as chemotherapy (e.g., carboplatin, paclitaxel), radiation therapy, and oncolytic viral therapy (e.g., OBP-301), have several known side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infection. Radiation therapy may lead to esophagitis, skin irritation, fatigue, and potential long-term effects like strictures. Oncolytic viral therapy, while still under investigation, may cause flu-like symptoms, injection site reactions, and potential off-target effects on normal cells. Combining these treatments can increase the severity and range of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for gastroesophageal junction adenocarcinoma, including pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting the PD-1 pathway. Pembrolizumab has shown efficacy in patients with high PD-L1 expression, while nivolumab has demonstrated improved overall survival in previously treated patients. Although specific FDA approvals for oncolytic virus therapies like OBP-301 are not mentioned, these immune-based therapies represent a similar approach in leveraging the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to OBP-301 for Gastroesophageal Junction Adenocarcinoma patients include: 1) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in various cancers including gastroesophageal junction adenocarcinoma. 2) Dostarlimab, another PD-1 inhibitor, which is an alternative for patients with dMMR tumors. 3) HER2-targeted therapies, such as trastuzumab, for HER2-overexpressing tumors. 4) Combination therapies involving cytotoxic chemotherapy with agents targeting specific genetic mutations or pathways, such as FOLFOX regimen combined with targeted agents. These alternatives have shown promise in clinical trials and may offer effective treatment options in 2024.

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Alkylating agents

Anti-Cancer Viral Therapy + Chemoradiation for Esophageal Cancer

Phase 1

Waitlist Available

Led By Geoffrey Y Ku

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception

Gastroesophageal junction tumors must be Siewert type I/II

Must not have

History or current symptoms of cardiac disease with specific classification

Tumor invasion of specific structures or presence of certain conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of a special virus, two chemotherapy drugs, and radiation therapy in patients with advanced esophageal or gastroesophageal cancer. The virus aims to kill cancer cells directly, while the chemotherapy and radiation help stop the cancer from growing and spreading.

Who is the study for?

This trial is for adults with advanced esophageal or gastroesophageal cancer who can't have surgery. They must be in good physical condition, not pregnant, and willing to use contraception. People with other cancers that won't affect this study can join too. But those with certain infections, previous treatments for their cancer, or serious health issues like uncontrolled diabetes cannot participate.

What is being tested?

The trial tests Telomelysin™ (OBP-301), a virus targeting cancer cells, combined with chemotherapy drugs carboplatin and paclitaxel plus radiation therapy. The goal is to see if this mix works better than the usual chemo and radiation for these types of cancer.

What are the potential side effects?

Possible side effects include normal cell infection by OBP-301, typical chemotherapy-related issues like nausea and hair loss, as well as skin irritation from radiation. There's also a risk of more severe reactions due to the body's response to the viral therapy.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant and agree to use birth control.

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My tumor at the stomach and esophagus junction is a specific type (Siewert I or II).

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I am HIV positive, on treatment, and my viral load is undetectable.

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I cannot have surgery but can undergo chemoradiation.

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My tumor can be treated with direct injections and I can undergo 3 endoscopies.

Exclusion Criteria

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

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I have a history of heart disease.

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My cancer has spread to nearby structures.

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I am currently breastfeeding.

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My cancer has spread to other parts of my body.

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I have had chemotherapy or radiotherapy for my cancer before.

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I do not have uncontrolled diabetes or an active infection needing IV antibiotics.

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I haven't taken immunosuppressive drugs in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Dose Limiting Toxicity

Secondary study objectives

Clinical Complete Response (cCR)

Incidence of Adverse Events

Overall Survival

+1 more

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: Treatment (OBP-301, carboplatin, paclitaxel, radiation)Experimental Treatment4 Interventions

Patients receive OBP-301 by intratumoral injection on days -3, 12, and 26. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gastroesophageal Junction (GEJ) Adenocarcinoma include chemotherapy, radiation therapy, and oncolytic viral therapy. Chemotherapy drugs like carboplatin and paclitaxel disrupt DNA replication, preventing cancer cell division. Radiation therapy uses high-energy x-rays to damage cancer cell DNA, leading to cell death. Oncolytic viral therapy, such as OBP-301, involves a virus engineered to selectively infect and destroy cancer cells, also stimulating an anti-tumor immune response. These mechanisms are vital for GEJ Adenocarcinoma patients as they guide the selection of effective, personalized treatment strategies.

Phase I dose-escalation study of endoscopic intratumoral injection of OBP-301 (Telomelysin) with radiotherapy in oesophageal cancer patients unfit for standard treatments.