Immunotherapy cocktail shows promise in shrinking esophageal tumors before surgery
NCT ID NCT04974047
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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70 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Oct 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
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Anhui Provincial Hospital
Hefei, Anhui, 230000, China
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Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
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Tangdu Hospital
Xi'an, Shaanxi, 710038, China
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy added to standard treatment aims to stop esophageal cancer from returning
- Can a Three-Drug cocktail shrink esophageal tumors before surgery?
- New drug duo aims to wipe out esophageal tumors before surgery
- Triple threat: immunotherapy and targeted drug join forces against esophageal cancer