Can early tumor response guide smarter cancer treatment?
NCT ID NCT07721103
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase II trial tests a personalized approach for people with locally advanced esophageal cancer. After initial chemoimmunotherapy, patients whose tumors shrink well go straight to surgery, while those with less response receive additional radiotherapy before surgery. The goal is to see if this response-guided strategy improves safety and outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of tislelizumab (PD-1 inhibitor), paclitaxel, cisplatin, and sequential radiotherapy
- What this could lead to
- If successful, this approach could offer a more personalized treatment plan for esophageal cancer, potentially improving surgical outcomes and survival.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. Adding radiotherapy also raises the risk of side effects like inflammation or tissue damage.
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 110 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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Dec 2031
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 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.
Inclusion Criteria: \- Participants must meet all of the following criteria: Provide written informed consent before enrollment. Age \>18 years, male or female. Histologically confirmed thoracic esophageal squamous cell carcinoma (ESCC). Locally advanced, resectable disease according to AJCC/UICC 8th edition TNM staging system, defined as: cT3-4aN0-2M0 or cT1-2N1-2M0; No evidence of distant metastasis; Considered initially resectable by a multidisciplinary surgical team. Patients who have received neoadjuvant chemoimmunotherapy and have measurable disease response assessment according to RECIST v1.1, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). At least one measurable lesion according to RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Expected survival time \>6 months. Adequate organ function meeting the following criteria: Bone marrow function: Absolute neutrophil count ≥1,500/mm³; Platelet count ≥100,000/mm³; Hemoglobin ≥9 g/dL. 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. Participants of childbearing potential must agree to use medically approved contraception during study treatment and for 3 months after completion of treatment. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and must not be breastfeeding. Willingness and ability to comply with study procedures, safety assessments, and survival follow-up. Exclusion Criteria: \- Participants will be excluded if any of the following criteria apply: Evidence of distant metastasis. Previous or concurrent malignancy, except adequately treated basal cell carcinoma of skin or cervical carcinoma in situ. Previous thoracic radiotherapy. Previous treatment with PD-1, PD-L1, or CTLA-4 inhibitors, or known hypersensitivity to PD-1 inhibitors or macromolecular protein products. Active autoimmune disease or history of clinically significant autoimmune disease requiring systemic treatment. Current use of immunosuppressive therapy or systemic corticosteroids exceeding the equivalent of prednisone 10 mg/day within 2 weeks before enrollment. Clinically significant ascites or pleural effusion requiring therapeutic drainage. Uncontrolled cardiovascular disease, including: NYHA class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year; Clinically significant arrhythmias requiring treatment. Significant coagulation abnormalities, bleeding tendency, or ongoing thrombolytic/anticoagulant therapy. Active gastrointestinal disorders associated with bleeding or perforation risk, including esophageal varices, active gastric/duodenal ulcer, ulcerative colitis, portal hypertension, or active tumor bleeding. History of severe bleeding, clinically significant hemoptysis, or thromboembolic events within specified periods. Active infection or unexplained fever \>38.5°C before treatment initiation. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment. History or evidence of interstitial lung disease, pulmonary fibrosis, radiation pneumonitis, drug-induced pneumonitis, pneumoconiosis, or severe pulmonary impairment. Known immunodeficiency, including HIV infection, or active hepatitis infection requiring exclusion according to protocol criteria. Participation in another clinical trial within 1 month before enrollment or concurrent systemic anticancer therapy. Receipt of live vaccines within 4 weeks before treatment or planned live vaccination during study treatment. Known history of substance abuse, alcoholism, or drug abuse. Inability or unwillingness to comply with study-related procedures, examinations, or required costs. Any other medical, psychological, social, or safety-related condition judged by the investigator to make the participant unsuitable for study participation.
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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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Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
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- Could more surgery and radiation after immunotherapy keep esophageal cancer at bay?
- Blood and tissue markers could forecast esophageal cancer return