Triple-Drug cocktail aims to tackle esophageal cancer that resists standard therapy

NCT ID NCT07686926

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This phase II trial tests a combination of three drugs—Becotatug Vedotin, Tislelizumab, and low-dose Lenvatinib—in people with advanced esophageal squamous cell carcinoma whose cancer has progressed after first-line therapy. The study aims to see if this triple therapy can shrink tumors and improve survival. Participants receive the drugs intravenously and orally over several cycles, with the main goal of measuring how many patients respond to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Becotatug Vedotin, Tislelizumab, and Lenvatinib
What this could lead to
If successful, this combination could offer a new second-line treatment option for people with advanced esophageal cancer who have run out of effective therapies.
What could go wrong
This is a small, early-phase study with only 36 participants, so results may not apply broadly. The combination of three drugs may cause significant 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

Phase 2

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

Participants

About 36 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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: 1.Age ≥ 18 years, male or female. 2.Histopathologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma. 3.Failed first-line or above standard systemic therapy for advanced disease. 4.Patients must be able to provide tumor specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic lesions for pathological testing. The most recent archived tumor tissue specimen may be used. If archived tissue is unavailable, a new biopsy is required. 5.ECOG PS 0-2. 6.Expected survival ≥ 3 months. 7.At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1 criteria. 8.Adequate organ and bone marrow function, as demonstrated by the following laboratory values: 1. Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;Platelet count (PLT) ≥ 100×10⁹/L;Hemoglobin (HGB)≥90 g/L. 2. Liver: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; for patients with liver metastases, ALT and AST≤5×ULN. 3. Kidney: Creatinine clearance (Ccr) ≥ 50 mL/min (calculated using the Cockcroft-Gault formula). 4. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for patients receiving therapeutic anticoagulation). 5. Cardiac function: No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%. 9.Female patients of childbearing potential must agree to use contraception during the study and for 6 months after the end of study participation, have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use contraception during the study and for 6 months after the end of study participation. 10.Patients must be able and willing to comply with the scheduled visits, treatment plans, laboratory tests, and other study-related procedures as outlined in the protocol. 11.Patients must be able to understand the study and voluntarily sign the informed consent form. Exclusion Criteria: 1. Prior malignancy within 5 years, except for carcinoma in situ, basal cell carcinoma, or other malignancies considered cured with negligible risk of recurrence. 2. Known hypersensitivity to any component of the study regimen. 3. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation. 4. Untreated or unstable parenchymal brain metastases, spinal cord metastasis or compression, leptomeningeal disease, or meningeal metastases. 5. Evidence of active infection, including:1)Hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU/mL, excluding drug-induced or other causes of hepatitis);2)Hepatitis C (anti-HCV antibody positive with HCV RNA above the lower limit of detection);3)Human immunodeficiency virus (HIV) infection;4)Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections that have not resolved prior to study drug administration. 6. Third-space fluid that cannot be controlled by drainage (e.g., massive ascites, pleural effusion, pericardial effusion), or subjects requiring drainage to control third-space fluid within 14 days prior to first dose. 7. Any severe or uncontrolled systemic disease in the investigator's judgment. 8. Poorly controlled cardiac disease, including: 1)Heart failure \> New York Heart Association (NYHA) class II; 2)Unstable angina pectoris; 3)Myocardial infarction within 1 year; 4)Clinically significant supraventricular or ventricular arrhythmias requiring treatment; 5)Long QT syndrome, with QTcF \> 450 ms (male) or QTcF \> 470 ms (female). 9.History of primary immunodeficiency or active autoimmune disease, or current use of immunosuppressants or systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) continuing within 2 weeks prior to enrollment. 10.History of or concomitant interstitial lung disease (ILD), radiation pneumonitis, severe chronic obstructive pulmonary disease (COPD), severe pulmonary insufficiency, or symptomatic bronchospasm. 11.Positive serum pregnancy test or breastfeeding females who do not agree to use adequate contraception during the study and for 6 months after the last dose of study drug. 12.History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. 13.Peripheral neuropathy ≥ Grade 2 (per CTCAE version 5.0). 14.Prior receipt of any of the following treatments: 1. Intravenous antibiotic therapy within 7 days prior to first dose. 2. Investigational drug from another clinical trial within 4 weeks prior to first dose. 3. Live attenuated vaccine within 4 weeks prior to first dose. Inactivated seasonal influenza vaccines or approved non-replicating COVID-19 vaccines are permitted. 4. Systemic immunostimulatory agents (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to first dose. 5. Major surgical procedure (e.g., abdominal or thoracic surgery, excluding diagnostic puncture, infusion device placement, or gastrointestinal stent placement) within 4 weeks prior to first dose, or anticipation of major surgery not directed at the tumor during the study treatment period. 15.History of substance abuse (psychoactive drugs) that cannot be abstained from, or psychiatric disorders. 16.Concurrent participation in another interventional clinical study. 17.Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.

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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.

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