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Immunotherapy cocktail shows promise in shrinking esophageal tumors before surgery

NCT ID NCT04974047

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether adding the immunotherapy drug tislelizumab to chemotherapy and/or radiation before surgery could help completely eliminate esophageal cancer in 70 patients. The goal was to see if the tumor and all cancer cells in lymph nodes were gone at the time of surgery. The study also tracked how many patients had clean surgical margins and how long they stayed cancer-free.

What this could mean

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

Active substance
tislelizumab (an immunotherapy drug) combined with chemotherapy (paclitaxel, cisplatin, 5-fluorouracil) and/or radiation
What this could lead to
If successful, this approach could increase the chance of completely removing esophageal cancer before surgery, potentially improving long-term outcomes.
What could go wrong
This is a small, early-phase trial (70 people) with no control group, so results may not be definitive. Side effects from the drug combination and radiation can be significant.

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

70 people

The number who actually took part.

Started

Aug 2021

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Key Inclusion Criteria: * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Histologically confirmed esophageal squamous cell carcinoma (ESCC). * Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition). * Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent. * Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose. Key Exclusion Criteria: * Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy. * Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways. * History of fistula due to primary tumor invasion. * Participants with high risk of fistula or sign of perforation evaluated by investigator. * Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose. \* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted. * Active autoimmune diseases or history of autoimmune diseases that may relapse. \* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases. * With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection. * Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. * Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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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.

Contacts and locations

Locations

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Tangdu Hospital

    Xi'an, Shaanxi, 710038, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

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