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Virus therapy joins Chemo-Radiation in fight against esophageal cancer

NCT ID NCT04391049

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Advanced esophageal adenocarcinoma Advanced gastroesophageal junction adenocarcinoma Clinical stage II esophageal adenocarcinoma ajcc V8 Clinical stage II gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage IIA esophageal adenocarcinoma ajcc V8 Clinical stage IIA gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage IIB esophageal adenocarcinoma ajcc V8 Clinical stage IIB gastroesophageal junction adenocarcinoma ajcc V8 Clinical stage III esophageal adenocarcinoma ajcc V8 Clinical stage III gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage II esophageal adenocarcinoma ajcc V8 Pathologic stage II gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage IIA esophageal adenocarcinoma ajcc V8 Pathologic stage IIA gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage IIB esophageal adenocarcinoma ajcc V8 Pathologic stage IIB gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage III esophageal adenocarcinoma ajcc V8 Pathologic stage III gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage IIIA esophageal adenocarcinoma ajcc V8 Pathologic stage IIIA gastroesophageal junction adenocarcinoma ajcc V8 Pathologic stage IIIB esophageal adenocarcinoma ajcc V8 Pathologic stage IIIB gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage II esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage II gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage III esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage III gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IIIA esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IIIA gastroesophageal junction adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IIIB esophageal adenocarcinoma ajcc V8 Postneoadjuvant therapy stage IIIB gastroesophageal junction adenocarcinoma ajcc V8 Squamous cell cancer Squamous cell carcinoma Unresectable gastroesophageal junction adenocarcinoma

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • City of Hope South Pasadena

    South Pasadena, California, 91030, United States

  • City of Hope Upland

    Upland, California, 91786, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

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