Short burst of radiation before Immuno-Chemo may boost esophageal cancer response
NCT ID NCT07678580
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether a short course of radiation followed by the immunotherapy drug tislelizumab plus chemotherapy can improve outcomes for people with a type of esophageal cancer that can be surgically removed. About 50 participants will receive either a low or high dose of radiation, then three cycles of tislelizumab and chemo, followed by surgery. The main goal is to see how many patients have no cancer cells left in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab, albumin-bound paclitaxel, carboplatin, and short-course radiotherapy
- What this could lead to
- If successful, this approach could increase the chance of eliminating all cancer before surgery, potentially improving long-term outcomes for people with esophageal cancer.
- What could go wrong
- This is an early Phase 2 study with only 50 participants, so results may not apply broadly. Side effects from the combination of radiation, immunotherapy, and chemotherapy could 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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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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: * Voluntarily provided written informed consent prior to any study-related procedures * Aged 18 to 75 years, male or female * Life expectancy of at least 3 months * Predicted to achieve R0 surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically confirmed, treatment-naive, resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) meeting the staging criteria: T1 N1-3 M0 or T2-4a N0-3 M0 (T2 ≥3 cm or poorly differentiated). No suspected metastatic cervical lymph nodes (except for upper thoracic esophageal cancer regional lymph nodes) on neck ultrasound or contrast-enhanced CT, and no distant metastasis on imaging * Presence of measurable tumor lesions. * Adequate organ function defined by laboratory parameters: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L. Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min. INR ≤1.5, PT and APTT ≤1.5×ULN * Men and women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose of study treatment * Good compliance and ability to complete scheduled follow-up. Exclusion Criteria: * Prior treatment with PD-1/PD-L1 inhibitors or other immunomodulatory agents targeting T-cell receptors (e.g., CTLA-4, OX40) * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage * Active or suspected autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, except type 1 diabetes controlled by replacement therapy, hypothyroidism, or skin disorders not requiring systemic therapy * History of grade ≥2 interstitial lung disease * Systemic corticosteroids (\>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days before first study treatment * Primary or acquired immunodeficiency, organ transplantation, allogeneic hematopoietic stem cell transplantation * Live vaccine within 4 weeks before first study treatment * Severe uncontrolled cardiovascular or cerebrovascular disease: Uncontrolled hypertension or pulmonary hypertension. Unstable angina, myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months. NYHA class ≥2 chronic heart failure. Left ventricular ejection fraction (LVEF) \<50%. Clinically significant arrhythmia requiring treatment. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months. Uncontrolled active infection requiring systemic antibiotics. Positive HIV test, active hepatitis B or hepatitis C infection (exceptions: HBV DNA \<500 IU/mL; HCV RNA undetectable). Active pulmonary tuberculosis (TB). Other active malignancy within the previous 2 years, except adequately treated thyroid cancer, carcinoma in situ of the cervix, basal/squamous cell skin cancer, or ductal carcinoma in situ of the breast * History of drug abuse or psychiatric disorder * Pregnant or lactating women * Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, would increase study-related risk or interfere with result interpretation.
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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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Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why does esophageal cancer come back after treatment? researchers search medical records for clues
- Which Pre-Surgery combo extends life in esophageal cancer? a virtual trial seeks answers
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?
- Can early tumor response guide smarter cancer treatment?
- Could a smart combo of drugs and radiation help some esophageal cancer patients skip surgery?