Can a triple therapy outsmart Hard-to-Treat esophageal cancer?
NCT ID NCT07769866
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial is investigating whether adding an experimental immunotherapy drug, retlirafusp alfa, to standard chemotherapy and radiation can help people with locally advanced esophageal squamous cell cancer that cannot be surgically removed. Participants will receive two cycles of the drug with chemotherapy before the standard chemoradiation, followed by maintenance immunotherapy for up to a year. The main goal is to see if this approach improves the chance of living without the cancer progressing for at least one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- retlirafusp alfa combined with chemotherapy and radiation
- What this could lead to
- If successful, this combination could offer a more effective treatment option for people with locally advanced esophageal cancer that cannot be removed by surgery, potentially delaying disease progression.
- What could go wrong
- This is an early-stage trial with a modest number of participants, so results may not be conclusive. The combination of immunotherapy, chemotherapy, and radiation may also increase the risk of side effects.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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 to 75 years
- 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: 1. Voluntarily sign the written informed consent form and agree to participate in this study; 2. Pathologically confirmed esophageal squamous cell carcinoma; 3. Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition); 4. Aged 18-75 years, male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6. No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; 7. Adequate major organ function, meeting the following laboratory criteria: Complete blood count: Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Blood biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 8. Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug, and must use effective contraception during the study period and for at least 3 months after the last dose; Male patients with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 3 months after the last dose. Exclusion Criteria: 1. Prior or concurrent treatment with any of the following: 1. Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy; 2. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose \> 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses \> 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease; 3. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug; 4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug; 2. Tumor-related exclusion criteria: 1. Non-esophageal cancer patients; 2. Patients without unresectable locally advanced or metastatic esophageal cancer; 3. Diagnosis of another malignancy within 5 years prior to the first dose of study drug, with the exception of cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery; 3. Other criteria: 1. Poorly controlled cardiac symptoms or diseases, including: a) New York Heart Association (NYHA) class ≥ 2 heart failure; b) Unstable angina; c) Myocardial infarction within 1 year; d) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 2. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring bronchodilators for medical intervention is excluded; 3. Pregnant or breastfeeding women; 4. History of severe allergic reactions to monoclonal antibodies, platinum agents, paclitaxel, or human serum albumin; 5. Human immunodeficiency virus (HIV)-positive patients, or patients with active hepatitis (hepatitis B reference: hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥ 2000 IU/mL or ≥ 10⁴ copies/mL; hepatitis C reference: hepatitis C virus (HCV) antibody positive), or active pulmonary tuberculosis; 6. Any other condition that, in the investigator's judgment, may necessitate premature termination from the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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