Virus therapy joins Chemo-Radiation in fight against esophageal cancer
NCT ID NCT04391049
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding a cancer-killing virus called OBP-301 to standard chemotherapy and radiation is safe for people with advanced esophageal or gastroesophageal cancer who cannot have surgery. The virus is designed to infect and destroy tumor cells. Sixteen participants will receive the combination, and researchers will monitor side effects closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OBP-301 (Telomelysin), a modified virus designed to infect and kill cancer cells
- What this could lead to
- If successful, this could lead to a more effective treatment option for patients with advanced esophageal cancer who cannot have surgery.
- What could go wrong
- This is a very early phase 1 trial with only 16 participants, focused on safety. The virus may cause side effects, and it is too soon to know if it improves outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ) within 90 days prior to registration * Gastroesophageal junction tumors must be Siewert type I/II * Required diagnostic workup for study entry: * History/physical examination prior to registration * Computed tomography (CT) of the chest/abdomen with intravenous contrast within 28 days prior to registration; If CT contrast is contraindicated magnetic resonance imaging (MRI) of the chest/abdomen without contrast is permitted * Bronchoscopy for squamous cell carcinoma (SCC) tumors that are adjacent to the airway to exclude a tracheoesophageal fistula within 42 days prior to registration * Endoscopic ultrasound (if technically feasible) within 90 days prior to registration * Whole body positron emission tomography (PET)/CT scan within 42 days prior to registration: Note: scan will be used for radiation treatment planning, in addition to ruling out metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration * Adequate hematologic function within 14 days prior to registration defined as follows Absolute neutrophil count ≥ 1,500/mcL (within 14 days prior to registration) Hemoglobin ≥ 9 gm/dL (within 14 days prior to registration) Platelets ≥ 100,000/mcL (within 14 days prior to registration) * Adequate renal function within 14 days prior to registration defined as follows Creatinine clearance of ≥ 50 ml/min (as calculated by Cockcroft-Gault equation) (within 14 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to registration) * AST/ALT ≤ 2.5 x ULN * Patients for whom non-operative management is a viable option in the opinion of a thoracic surgeon and/or multidisciplinary team and are candidates for chemoradiation; this does not preclude patients from receiving surgery after chemoradiation if felt to me medically indicated; * Patients must, in the opinion of a treating gastroenterologist, have a tumor that is amenable to intratumoral injection with at least 1 mL (1 x 10\^12 vp/mL) of OBP-301 and be a candidate for 3 endoscopy procedures * Female patients of child bearing potential must have a negative serum/urine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months * Patients of reproductive potential must agree to use effective contraception for the duration of study treatment as well as 6 months (for women) or 12 months (for men) after the last administered injection of OBP-301. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method or intrauterine device * The patient must provide study-specific informed consent prior to study entry * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Known acute or chronic hepatitis B or C infection (testing not required prior to study entry in patients with no known history of hepatitis B or C) * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * For patients with a history of hepatitis C virus (HCV) infection, they must (i) have been treated and cured, (ii) for patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to study entry are eligible for this trial Exclusion Criteria: * Definitive clinical or radiologic evidence of metastatic disease including: * Positive malignant cytology of the pleura, pericardium or peritoneum * Radiographic evidence of involvement of any adjacent mediastinal structure, e.g. aorta, trachea, which would increase the risk of repeated endoscopic interventions * Tracheoesophageal fistula * Radiographic evidence of distant organ involvement * Non-regional lymph nodes that cannot be contained within a radiation field * More than 1 esophageal lesion * Prior systemic chemotherapy for the study cancer * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Biopsy-proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula or recurrent laryngeal or phrenic nerve paralysis * For patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, a New York Heart Association functional classification 2C or worse * Uncontrolled diabetes * Infection requiring IV antibiotics at the time of registration * Patients requiring immunosuppressive medications including chronic suppressive steroid therapy (greater than the equivalent of 20 mg/day of prednisone), methotrexate, azathioprine and TNF-alpha blockers within 7 days prior to study entry * Received live vaccine within 30 days prior to registration * Received a blood transfusion, hematopoietic agent; granulocyte-colony stimulating factor (G-CSF), and/or oxygen supplementation within 7 days before the screening lab * Breast feeding females
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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City of Hope South Pasadena
South Pasadena, California, 91030, United States
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City of Hope Upland
Upland, California, 91786, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
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University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
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University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Antibody-Drug conjugate targets advanced esophageal cancer after standard treatments fail
- Can a drug combo stop esophageal cancer from returning after surgery?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Can a direct hit to tumors make immunotherapy work better?
- Can a vaccine stop GI cancers from returning?