Can a Triple-Drug combo shrink esophageal tumors before surgery?

NCT ID NCT07799077

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether giving a combination of immunotherapy (sintilimab) and two chemotherapy drugs (paclitaxel polymeric micelles and cisplatin) before surgery can help people with a certain type of esophageal cancer. The treatment aims to shrink tumors and improve the chance of successful surgery. The study includes adults with resectable, locally advanced esophageal squamous cell carcinoma who have not had prior treatment. Researchers will measure how many patients have no cancer cells left in the removed tissue, as well as overall survival and side effects.

What this could mean

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

Active substance
A combination of three drugs given before surgery: sintilimab (an immunotherapy), paclitaxel polymeric micelles (a form of chemotherapy), and cisplatin (another chemotherapy).
What this could lead to
If successful, this approach could shrink tumors before surgery, potentially improving survival and offering a new standard of care for patients with this type of esophageal cancer.
What could go wrong
This is a small, early-phase trial, so results may not hold up in larger studies. The combination may cause significant side effects, including immune-related reactions, and may not improve outcomes for 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

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.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 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. Written informed consent was signed before the implementation of any test-related procedures ; 2. Age 18-75 years ; 3. Esophageal squamous cell carcinoma confirmed by histopathology ; 4. Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ; 5. No anti-tumor treatment has been received ; 6. ECOG PS 0-1 ; 7. Expected survival ≥ 3 months ; 8. At least one measurable lesion per RECIST v1.1; 9. Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ; 10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within three days prior to the first study drug administration ( day 1 of the first cycle ). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-fertility age were defined as at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy ; 11. If there is a risk of conception, all subjects ( male or female ) are required to use contraception with an annual failure rate of less than 1 % throughout the treatment period up to 120 days after the last study drug administration ( or 180 days after the last study drug administration ). Exclusion Criteria: 1. High risk of tracheoesophageal fistula or aortoesophageal fistula 2. Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy 3. Participation in another interventional clinical trial within 4 weeks before the first dose 4. History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ) 5. Active uncontrolled hepatitis B/C infection 6. Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression) 7. Allergy to study drugs or excipients 8. Uncontrolled third-space effusion (e.g., pleural/pericardial effusion) 9. Pregnant or lactating women

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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

  • The Fourth Hospital of Hebei Medical University

    Hebei, Shijiazhuang, China

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