Esophageal Cancer
Conditions
Interventions
Experimental Group:Concurrent Chemoradiotherapy followed by Surgery
Controlled Group:Surgery alone
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Age: 18–75 years (male or female). 2.Histologically confirmed, locally advanced (clinical stage: cT1N2-3M0 or cT2-4aN0-3M0, Stage II–IVA) thoracic esophageal squamous cell carcinoma (ESCC) per AJCC 8th Edition (2017) staging criteria. 3.Surgically resectable locally advanced ESCC upon pretreatment evaluation. 4.Measurable lesion(s) meeting RECIST v1.1 criteria for evaluation. 5.ECOG performance status: 0–1. 6.Life expectancy >=6 months. 7.Adequate organ function (no blood transfusions or growth factors within 14 days prior to screening): 8.Bone marrow function:Absolute neutrophil count (ANC) >=1,500/mm^3;Platelet count >=100,000/mm^3;Hemoglobin >=9 g/dL (5.6 mmol/L) 9.Renal function:Serum creatinine =60 mL/min 10.Hepatic function:Total bilirubin <=1.5 × ULN;AST & ALT <=1.5 × ULN;Contraception requirements: 11.Non-sterilized or fertile female patients: Must use medically approved contraception (e.g., IUD, oral contraceptives, or condoms) during treatment and for 3 months after treatment completion.Female patients of childbearing potential: Negative serum/urine pregnancy test (HCG) within 7 days before enrollment; must be non-lactating.Non-sterilized male patients: Must agree to use medically approved contraception with their partner during treatment and for 3 months after treatment completion. 12.Voluntary participation: Patients must voluntarily enroll, demonstrate good compliance, and commit to safety and survival follow-up.Additional Requirement for Non-CCR Patients After Neoadjuvant Therapy: 13.Patients who complete 2 cycles of paclitaxel + carboplatin chemotherapy combined with tislelizumab (anti-PD-1) and are assessed as non-complete clinical response (non-CCR) must re-sign the formal informed consent before further treatment allocation.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients meeting any of the following criteria will be excluded from the study: 1. Radiologically confirmed distant metastasis. 2. History or concurrent malignancy (except cured basal cell carcinoma or cervical carcinoma in situ). 3. Active or history of autoimmune diseases, including but not limited to: - Autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. - Exemptions: Vitiligo, childhood asthma (fully resolved in adulthood without intervention). - Exclusion: Asthma requiring bronchodilators or medical intervention. 4. Current use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone or equivalent) for immunosuppression within 2 weeks before enrollment. 5. Symptomatic ascites or pleural effusion requiring therapeutic drainage. 6. Poorly controlled cardiac conditions, including: - NYHA Class II+ heart failure. - Unstable angina. - Myocardial infarction within 1 year. - Clinically significant arrhythmias requiring treatment. 7. Coagulation disorders (PT >16 s, APTT >43 s, TT >21 s, Fbg 30 mL hemorrhage within 3 months. - Hemoptysis (>5 mL fresh blood within 4 weeks). - Thromboembolic events (e.g., stroke/TIA) within 12 months. 10. Active infection or unexplained fever >38.5°C before first dose (tumor-related fever allowed per investigator judgment). 11. Abdominal fistula, GI perforation, or abscess within 4 weeks prior to treatment. 12. Objective evidence of pulmonary fibrosis, interstitial lung disease (ILD), pneumoconiosis, radiation pneumonitis, or drug-induced pneumonia. 13. Immunodeficiency or active hepatitis: - HIV infection. - Active HBV (HBV DNA =104 copies/mL) or HCV (HCV RNA =10³ copies/mL). - Chronic HBV carriers (HBV DNA <2000 IU/mL) must receive antiviral therapy during the study. 14. Concurrent clinical trials or participation within 1 month prior to enrollment. 15. Live vaccines administered within 4 weeks before treatment or planned during the study. 16. History of substance abuse, alcoholism, or drug addiction. 17. Inability/unwillingness to cover out-of-pocket costs (excluding study drugs, combined chemoradiotherapy, and related SAEs). 18. Other exclusions per investigator discretion: - Severe comorbidities (including psychiatric disorders) requiring additional treatment. - Critical lab abnormalities. - Social/family factors compromising safety or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;Event Free Survival;Overall Survival;Clinical complete response rate before surgery;R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital
Outcome results
None listed