New combo therapy aims to boost survival in tough esophageal cancer cases
NCT ID NCT05189730
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tests whether adding the immunotherapy drug tislelizumab to chemotherapy after standard chemoradiation can improve outcomes for people with locally advanced esophageal cancer who are at high risk. About 80 participants will receive the combination before surgery, then get more treatment based on their results. The goal is to see if this approach can help high-risk patients live longer while avoiding extra side effects for those at lower risk.
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 paclitaxel and carboplatin (chemotherapy drugs)
- What this could lead to
- If successful, this could lead to a more personalized treatment approach for esophageal cancer, helping high-risk patients live longer while sparing low-risk patients from unnecessary side effects.
- What could go wrong
- This is an early-phase exploratory study with only 80 participants, so results may not apply broadly. The combination therapy also carries risks of side effects from both immunotherapy and chemotherapy.
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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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- 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.
Inclusion Criteria: * 1.Histologically confirmed ESCC; * 2.Clinical stage T2N0-1M0, T3N0M0, T3N1M0, T1-3N2M0(II-III) (AJCC 8 TNM classif tion); * 3.Locally advanced ESCC that can be treated surgically evaluated before treatment; * 4.At least one measurable lesion in accordance with RECIST 1.1; * 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; * 6.Expected survival time is greater than 6 months; * 7.The important organs functions meet the following requirements:the absolute neutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L; bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5 times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal; * 8.Female subjects of childbearing potential have a negative pregnancy test and must agree to take effective contraceptive measures during the study period and within 3 months after the last dose; * 9.Be willing and able to provide written informed consent/assent for the trial. Exclusion Criteria: * 1.The patient have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy; * 2.Confirmed patients with distant metastasis by CT imaging; * 3.The subject has previous or co-existing other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * 4.The subject had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1; * 5.Patients with active autoimmune disease or documented autoimmune disease or symptoms requiring systemic hormone therapy or anti-autoimmune drug therapy; * 6.Patients with immunodeficiency or who were still receiving systemic steroid hormone therapy (prednisone \> 10 mg/ day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days prior to the first dose of neoadjuvant therapy in this study; * 7.Clinical ascites or pleural effusion requiring therapeutic puncture or drainage; * 8.The subject with uncontrol cardiac clinical symptoms or diseases, such as :(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention; * 9.Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\> 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment; * 10.The subject is present (within 3 months) with esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or with active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; * 11.Past or present severe bleeding (bleeding \>30 ml within 3 months), hemoptysis (fresh blood \>5 ml within 4 weeks) or thromboembolism events (including stroke events and/or TRANSIENT ischemic attack) within 12 months; * 12.Patients with active infection who still required systemic treatment 7 days before the first dose of neoadjuvant therapy in this study; * 13.Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc; * 14.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus; * 15.Senior or uncontrolled virus injection: HIV, TP, hepatitis virus; * 16.Patients who had participated in clinical trials of other drugs within 4 weeks; * 17.The live vaccine was administered less than 4 weeks prior to study administration or possibly during the study period; * 18.Have a history of mental illness or psychiatric substance abuse; * 19.The subject cannot or does not agree to bear the cost of the self-paid portion of the examination and treatment, except for the clinical study drug, combined chemoradiotherapy, and SAE associated with the clinical study drug; * 20.Other patients whom the medical practitioner considers inappropriate for inclusion.
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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
-
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?
- Can a Triple-Drug combo wipe out esophageal tumors before surgery?
- Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer