Immunotherapy duo takes on esophageal cancer before surgery
NCT ID NCT07493993
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of two immune-boosting drugs (iparomlimab and tuvonralimab) plus chemotherapy before surgery in 26 patients with locally advanced esophageal cancer. The goal is to see if this approach can completely eliminate cancer cells in the removed tissue. The study is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and Tuvonralimab (a dual antibody targeting PD-1 and CTLA-4) plus Nab-Paclitaxel chemotherapy
- What this could lead to
- If successful, this could offer a more effective pre-surgery treatment to shrink tumors and improve outcomes for patients with esophageal cancer.
- What could go wrong
- This is a small, early-phase trial with only 26 participants. The combination may cause significant side effects, and results may not apply to all patients.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 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: * Voluntarily understand and sign the informed consent form for this study. * Age ≥ 18 years, male or female. * Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition). * ECOG performance status of 0-2. * No prior treatment for esophageal squamous cell carcinoma. * Life expectancy ≥ 3 months. * Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10\^9/L; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 80 × 10\^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%. * Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose. Exclusion Criteria: * Inability to comply with the study protocol or study procedures. * Presence of supraclavicular lymph node metastasis. * Obvious tumor invasion of organs adjacent to the esophageal lesion. * Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment. * Allergy or known hypersensitivity to the study drugs or their excipients. * Anticipated need for systemic corticosteroids or other immunosuppressive therapy during the study treatment period. * Active autoimmune disease requiring systemic treatment, or a history of autoimmune disease. * Positive HIV test; positive hepatitis B surface antigen with HBV-DNA \> upper limit of normal; active hepatitis C virus (HCV) infection. * History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months before the first study drug administration; known severe varices on endoscopy within 3 months before the first study drug administration. * Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia that might interfere with the assessment and management of immune-related pulmonary toxicity. * Evidence of a significant bleeding tendency or other major coagulation disorders. * Severe cardiovascular or cerebrovascular disease. * Other malignancies within 5 years before enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. * History of allogeneic bone marrow transplantation or organ transplantation. * Patients considered by the investigator to be unsuitable for participation in this 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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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sparing lymph nodes: targeted radiation plus immunotherapy takes aim at esophageal tumors
- Can a pair of PET scans reveal who will beat esophageal cancer?
- Two-Drug cocktail aims to shrink Hard-to-Treat esophageal and stomach tumors
- New drug duo aims to wipe out esophageal tumors before surgery
- Could a drug combo let some esophageal cancer patients skip surgery?
- New drug cocktail shows promise against tough esophageal cancer