Can a drug combo turn inoperable esophageal cancer into a surgical target?
NCT ID NCT07549100
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a combination of tislelizumab (an immunotherapy) and chemotherapy can shrink advanced esophageal tumors enough to allow surgery. Thirty patients with initially inoperable cancer will receive 2-4 cycles of the drug combo, then be reassessed for surgery. The main goal is to see how many become eligible for surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab plus chemotherapy (albumin-bound paclitaxel and cisplatin or carboplatin)
- What this could lead to
- If successful, this approach could allow more patients with advanced esophageal cancer to undergo potentially curative surgery.
- What could go wrong
- This is a small, early-phase study with only 30 participants and no comparison group. The combination may cause significant side effects, and not all tumors may shrink enough for surgery.
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.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
- 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. Written informed consent is obtained prior to any study-related procedures. 2. Age 18 to 75 years, inclusive; both male and female patients are eligible. 3. Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as: T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases. 4. No evidence of distant metastasis. 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 7. Estimated life expectancy of ≥6 months. 8. Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment): Hematologic function: absolute neutrophil count (ANC) ≥1,500/mm³; platelet count ≥100,000/mm³; hemoglobin ≥9 g/dL (5.6 mmol/L). Renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min. Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN. 9. For women of childbearing potential: must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use a medically acceptable method of contraception (e.g., intrauterine device, oral contraceptives, or barrier methods) during the study treatment period and for at least 3 months after the last dose. For men with partners of childbearing potential: must agree to use a medically acceptable method of contraception during the study treatment period and for at least 3 months after the last dose. 10. Willingness to participate in the study, good compliance, and ability to adhere to study procedures, including safety and survival follow-up. Exclusion Criteria: 1. Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer. 2. Evidence of distant metastasis confirmed by imaging. 3. History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. 4. Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab. 5. Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. 6. Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible. 7. Patients with asthma requiring bronchodilator therapy are not eligible. 8. Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment. Clinically significant ascites or pleural effusion requiring therapeutic drainage. Uncontrolled or clinically significant cardiovascular disease, including but not limited to: New York Heart Association (NYHA) class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year prior to enrollment; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 9. Coagulation abnormalities, defined as: prothrombin time (PT) \>16 seconds, activated partial thromboplastin time (APTT) \>43 seconds, thrombin time (TT) \>21 seconds, or fibrinogen (Fbg) \>2 g/L; or presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy. 10. Presence of gastrointestinal conditions associated with a high risk of bleeding or perforation within 3 months prior to enrollment, including but not limited to esophageal varices, active gastric or duodenal ulcers, ulcerative colitis, portal hypertension, or unresected tumors with active bleeding; or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shandong Provincial Hospital
RECRUITINGJinan, Shandong, 250000, China
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Other studies related to the condition(s) this trial covers.
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