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New drug cocktail aims to wipe out esophageal cancer before surgery

NCT ID NCT07490002

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is testing whether adding two immunotherapy drugs (iparomlimab and tuvonralimab) and a targeted therapy (lenvatinib) to standard chemotherapy before surgery can improve outcomes for people with resectable esophageal squamous cell carcinoma. The main goal is to see how many patients have no cancer cells left in their surgical specimen (pathological complete response). The study will enroll 33 participants and 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, tuvonralimab, lenvatinib, cisplatin/carboplatin, nab-paclitaxel
What this could lead to
If successful, this could lead to a more effective pre-surgery treatment for esophageal cancer, potentially increasing the chance of eliminating all cancer before surgery.
What could go wrong
This is a small, early-phase study (33 people) with no control group, so results may not be definitive. The drug combination may cause significant side effects and may not improve outcomes compared to standard care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Nov 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 to 75 years

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: * Gender: no restriction; Age: 18-75 years. * Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma. * Clinical stage II-IVa (T2-4aN+M0) according to the AJCC 8th edition, and assessed as resectable by a multidisciplinary team (MDT). * Complete imaging work-up shows no evidence of distant metastasis: 1. Neck ultrasound and contrast-enhanced chest/abdominal CT. 2. Ultrasound-guided lymph node biopsy or PET/CT if clinical suspicion or neck ultrasound suggests cervical lymph node metastasis. 3. Abdominal non-contrast and contrast-enhanced MRI or PET/CT to confirm diagnosis if CT suggests liver metastasis. 4. Bone scan if necessary in case of systemic bone pain symptoms. 5. Endoscopic ultrasound for accurate staging. * No prior antitumor therapy received (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine). * ECOG Performance Status score: 0-1. * Adequate organ function, meeting the following laboratory criteria (no blood transfusion, granulocyte colony-stimulating factor \[G-CSF\], or corrective medication within 14 days prior to treatment): 1)Hemoglobin (Hb) ≥90 g/L. 2)Absolute neutrophil count (ANC) ≥1.5×10⁹/L. 3)Platelet count (PLT) ≥100×10⁹/L. 4)Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN). 5)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. 6)Serum creatinine clearance (CrCl) ≥50 mL/min (calculated by Cockcroft-Gault formula). 7)Coagulation: International normalized ratio (INR) ≤1.5 × ULN, activated partial thromboplastin time (APTT) ≤1.5 × ULN. 8)Proteinuria \< 2+ (if ≥ 2+, a 24-hour urine protein quantification must be performed; patients are eligible if the result is ≤1 g). 9)Left ventricular ejection fraction (LVEF) ≥50%. * No surgical contraindications. * The subject agrees to use effective contraception from the signing of the informed consent form until 180 days after the last dose. Female subjects of childbearing potential must not be pregnant or breastfeeding. * Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: * Known history of hypersensitivity to macromolecular protein preparations. Contraindications or allergies to any component of epaplimut-pembrolizumab. * Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, anti-tumor traditional Chinese herbal medicine). * Radiographic diagnosis indicating distant metastasis of the tumor. * History of allogeneic tissue/solid organ transplantation. * Within 2 weeks prior to the first dose, presence of a condition requiring systemic corticosteroid (\>10 mg daily prednisone or equivalent) or other immunosuppressive medication (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.). Topical, nasal spray, and inhaled corticosteroids are permitted. Prophylactic use of systemic corticosteroids for contrast agent allergy is allowed. * Active or potentially recurrent autoimmune diseases, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes requiring only stable-dose insulin replacement therapy. * Other active malignancies within the past 5 years, except for cured localized cancers (e.g., basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast) and breast cancer without recurrence for more than 3 years after radical surgery. * History of interstitial lung disease and/or pneumonitis or pulmonary hypertension. * Poorly controlled ascites, pericardial effusion, or pleural effusion requiring repeated drainage. * Poorly controlled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) and diabetes despite standard treatment, or uncontrolled or symptomatic arrhythmia. * Thromboembolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism. * Myocardial infarction within the past 12 months, severe/unstable angina, or symptomatic congestive heart failure (NYHA class III or IV). * Participation in other clinical trials within 60 days prior to or during the treatment period. * Known active infection with HIV, HBV, or HCV. * Major surgery (excluding needle biopsy) within 4 weeks prior to the first dose without full recovery. * Any other condition deemed by the investigator as inappropriate for inclusion 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

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  1. The official record

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