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New drug cocktail aims to tackle tough esophageal cancer

NCT ID NCT06339619

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 trial is testing a combination of three drugs—adebrelimab, apatinib, and tegafur—in 32 people with advanced esophageal cancer that has not responded to first-line immunotherapy. The goal is to see if this new mix can shrink tumors or slow the disease. Participants will receive the drugs intravenously and orally over several weeks.

What this could mean

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

Active substance
adebrelimab (an immunotherapy drug), apatinib (a targeted therapy), and tegafur (a chemotherapy drug)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced esophageal cancer that has stopped responding to standard immunotherapy.
What could go wrong
This is a small, early-phase trial with only 32 participants, so results may not apply to everyone. The combination of drugs may cause significant side effects, and there is no guarantee it will work better than existing options.

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 32 people

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

Started

Mar 2024

Expected to finish

Sep 2028

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: 1. 18-75 years old, both sexes. 2. Esophageal squamous cell carcinoma confirmed by histology or cytology with locally advanced unresectable or distant metastasis (according to AJCC 8th edition). 3. ECOG PS score of 0 \~ 1. 4. Expected survival ≥3 months. 5. Patients who have failed first-line immunotherapy combined with chemotherapy. 6. At least one measurable or unmeasurable lesion according to RECIST V1.1 criteria (subjects with intracranial lesions alone were excluded from this study). 7. Ability to swallow investigational drugs . 8. The functional level of the organ must meet the following requirements. (1) ANC≥1.5×109/L; (2) PLT≥100×109/L; (3) Hb≥90 g/L; (4) Serum albumin ≥30 g/L; (5) TBIL≤1.5×ULN; ALT and AST≤2.5 x ULN; For patients with liver metastases, ALT and AST≤5×ULN; (6) Cr ≤1.5×ULN, or creatinine clearance ≥50mL/min as calculated by the Cockcroft-Gault formula; (7) Patients with urinary protein ≥++ should undergo further 24-hour quantitative detection of urinary protein, and the detection result should be\<1.0g. 9. Within 7 days prior to enrollment, women of reproductive age must confirm a negative serum pregnancy test and consent to use effective contraception during the study drug use period and within 2 months after the last dose. 10. Subjects voluntarily participate in the study after fully informed consent and sign the informed consent. Exclusion Criteria: 1. Have been diagnosed with other malignancies within 5 years, excluding: curable carcinoma in situ of the cervix, skin basal cell carcinoma or squamous cell carcinoma, or any other tumor that has been cured . 2. Patients who had previously received treament of Adebrelimab, Apatinib or Tegafur. 3. The following conditions occurred in the previous treatment history. (1)Used Chinese medicine anti-tumor treatment within 2 weeks; (2)Received other anti-tumor therapy within 4 weeks, including but not limited to chemotherapy, radiotherapy, and targeted therapy. 4. Have not recovered from adverse events caused by prior antitumor therapy (i.e., ≤ grade 1 or at baseline). 5. Subjects who have participated in or are participating in other clinical trials within 4 weeks. 6. Received major surgery within 4 weeks or anticipated to undergo major surgery during the study period. 7. Subject is currently using a CYP3A strong inhibitor or inducer, or has discontinued a strong inhibitor for less than 5 half-lives of the medication or discontinued a strong inducer for less than 5 half-lives of the medication or 14 days (whichever is longer) before dosing. 8. Current need for treatment of central nervous system metastases or uncontrolled central nervous system metastases. 9. Risk of severe bleeding or esophageal fistula. 10. Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the drug. 11. Those with active gastrointestinal ulcers, active gastrointestinal bleeding, or perforation. 12. Within the 12 months prior to enrollment, individuals with any of the following conditions: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass grafting surgery, congestive heart failure (III-IV graded by New York Heart Association), etc.; unstable angina within the 6 months prior to enrollment. 13. Within the 12 months prior to enrollment, occurrence of thrombotic events or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, etc., or patients currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or other similar medications. 14. Fridericia-corrected QT interval (QTcF)\>470 ms; history of congenital long QT syndrome; history of any clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); left ventricular ejection fraction (LVEF) \<50%. 15. Those with uncontrollable pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage. 16. Past or current interstitial lung disease or immune-related pneumonia; currently suffering from drug-induced pneumonia, radiation pneumonia requiring steroid therapy, or clinically symptomatic active pneumonia, or other moderate to severe pulmonary diseases severely affecting lung function. 17. Active infection during screening, or unexplained fever\>38.5°C within 2 weeks prior to randomization. 18. Active hepatitis B or hepatitis C. 19. Received live vaccines within 4 weeks prior toenrollment and/or planned to receive live vaccines after enrollment. 20. Those with congenital or acquired immunodeficiency (such as HIV-infected individuals). 21. History of organ transplantation or allogeneic bone marrow transplantation. 22. Individuals deemed by the investigator to have other serious acute or chronic illnesses unsuitable for participation in the 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, Guangdong, 510030, China