NCT04973306 Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC
| NCT ID | NCT04973306 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Esophageal Squamous Cell Carcinoma Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2024-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 176 participants in total. It began in 2022-03-02 with a primary completion date of 2024-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically-confirmed esophageal squamous cell carcinoma and whose tissue samples were taken before treatment; 2. Tumors of the esophagus are located in the thoracic cavity; 3. Pre-treatment stage as clinical II-III (AJCC/UICC 8th Edition) 4. Age is between 18 years and 75 years; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and expected survival time ≥12 months; 6. 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 %; 7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests ; 8. Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L); 9. Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN); 10. Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L); 11. The patient has provided written informed consent and is able to understand and comply with the study; Exclusion Criteria: Exclusion Criteria associated with Cancer: 1. Patients with histological non-squamous cell carcinoma; 2. Patients with advanced non-operable or metastatic esophageal cancer; 3. 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; 4. 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; 5. Patients who have received or are receiving other chemotherapy, radiotherapy or targeted therapy; Other Exclusion Criteria: 6. Patients with autoimmune diseases history; 7. Recently or currently taking Glucocorticoids or Immunosuppressants; 8. Patients who underwent immunotherapy in the past; 9. Allergy to any antibody drugs or allergy to Paclitaxel and Carboplatin. 10. Past or currently suffering from chronic or recurrent autoimmune diseases; 11. 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; 12. Patients with organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 13. 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; 14. 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), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder; 15. Pregnant or lactating women and fertile women who will not be using contraception during the trial; 16. 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; 17. Expected lack of compliance with the protocol.
Contact & Investigator
Lijie Tan, MD
PRINCIPAL INVESTIGATOR
Shanghai Zhongshan Hospital
Frequently Asked Questions
Who can join the NCT04973306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04973306 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04973306 currently recruiting?
Yes, NCT04973306 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Zhongshan Hospital to inquire about joining.
Where is the NCT04973306 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04973306 clinical trial?
NCT04973306 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Lijie Tan, MD at Shanghai Zhongshan Hospital. The trial plans to enroll 176 participants.