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Compares treatment options for Esophageal Squamous Cell Carcinoma Stage II
Official title Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC
ClinicalTrials.gov ID: NCT04973306
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma stage ii.
Also referred to as anti-PD-1 antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study was to evaluate the safety, feasibility and outcome of anti-PD-1 antibody (Tislelizumab, BeiGene) combined with neoadjuvant chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by minimally invasive esophagectomy for locally advanced resectable esophageal squamous cell carcinoma (cII-III Stage) patient.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically-confirmed esophageal squamous cell carcinoma and whose tissue samples were taken before treatment;
- Tumors of the esophagus are located in the thoracic cavity;
- Pre-treatment stage as clinical II-III (AJCC/UICC 8th Edition)
- Age is between 18 years and 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and expected survival time ≥12 months;
You likely can't join if
- Exclusion Criteria associated with Cancer:
- Patients with histological non-squamous cell carcinoma;
- Patients with advanced non-operable or metastatic esophageal cancer;
- Pre-treatment stage as cM+, cN3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 8th Edition) or cTis-1a...
- Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the...
- Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy; Other Exclusion Criteria:
See the full eligibility criteria
- Histologically-confirmed esophageal squamous cell carcinoma and whose tissue samples were taken before treatment;
- Tumors of the esophagus are located in the thoracic cavity;
- Pre-treatment stage as clinical II-III (AJCC/UICC 8th Edition)
- Age is between 18 years and 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and expected survival time ≥12 months;
- Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \> 50 %;
- Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests ;
- Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L);
- Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN);
- Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L);
- The patient has provided written informed consent and is able to understand and comply with the study;
- Exclusion Criteria associated with Cancer:
- Patients with histological non-squamous cell carcinoma;
- Patients with advanced non-operable or metastatic esophageal cancer;
- Pre-treatment stage as cM+, cN3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 8th Edition) or cTis-1a, cT1bN0;
- Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator;
- Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy; Other Exclusion Criteria:
- Patients with autoimmune diseases history;
- Recently or currently taking Glucocorticoids or Immunosuppressants;
- Patients who underwent immunotherapy in the past;
- Allergy to any antibody drugs or allergy to Paclitaxel and Carboplatin.
- Past or currently suffering from chronic or recurrent autoimmune diseases;
- Patients with active infection of immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); HIV seropositivity; HBV DNA or HCV RNA positive;
- Patients with organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
- Patients with severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
- Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months)...
- Pregnant or lactating women and fertile women who will not be using contraception during the trial;
- Participation in another intervention clinical trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention during this study or during the last 30 days prior to informed consent;
- Expected lack of compliance with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.