New combo therapy shows promise for tough esophageal cancer
NCT ID NCT04229459
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests adding two drugs, nivolumab and cetuximab, to standard chemoradiation for people with a type of esophageal cancer that hasn't spread far. The goal is to see if this combination can make tumors disappear before surgery. The study involves 12 adults who haven't had prior treatment for this cancer, and they receive the drugs alongside radiation and chemotherapy, followed by surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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12 people
The number who actually took part.
- Started
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Feb 2020
- Expected to finish
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Apr 2027
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: * Signed written IRB approved informed consent. * Age \> 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Subjects with histologically confirmed operable, primary (non-recurrent) locally advanced (T3NxM0, TxN1M0) middle (distal to the thoracic inlet) or distal (up to the gastroesophageal junction) ESqCC according to endoscopic ultrasound (EUS) and PET-CT. * No prior systemic or radiation therapy for esophageal cancer. * Presence of adequate contraception in fertile patients. * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. * Women must not be breastfeeding. * No previous (within the last 5 years) or concurrent malignancies, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the skin. Exclusion Criteria: * Cervical esophageal tumors or tumors \< 5 cm from the cricopharyngeal cartilage. * Gastric cancers with minor involvement of the GEJ or distal esophagus, or an esophageal tumor extending beyond 2 cm into the stomach. * Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years or prior esophageal or gastric surgery. * Patients with evidence of metastatic disease. * Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheo-esophageal (TE) fistula or recurrent laryngeal nerve or phrenic nerve paralysis. * New York Heart Association Class III or IV heart disease. Angina or myocardial infarction within the last 12 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality. * Clinically significant hearing loss. * Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication. * Any positive test for hepatitis B virus or hepatitis C virus indicating active infection. * Ongoing immunosuppressive therapy. * Active autoimmune disease. \[Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\]. * Prior organ transplant. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
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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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Rabin Medical Center
Petah Tikva, Israel
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?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?