Esophageal squamous cell carcinoma
Conditions
Interventions
Reduced-dose Chemotherapy Combined with Immunotherapy Group:Toripalimab 240mg, d1
Nab-paclitaxel ,150mg/m2, d1
Carboplatin, AUC=3, d1, Q3W, 4 Cycles
Conventional-dose Chemotherapy Combined with Immunotherapy Group:Toripalimab 240mg, d1
Nab-paclitaxel, 130mg/m2, d1, d8
Carboplatin, AUC=2.5, d1, d8, Q3W, 4 Cycles
Experimental group (Stage II):(1) If the cCR rate is comparable (with an acceptable difference of less than 10% in cCR rate), the safer medication regimen will be selected to enter the second phase.
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Sponsors
The First Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
70 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC). 2) Ages 70 to 80 years, inclusive, with no gender restrictions. 3) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4) Patients who have not previously received chemotherapy, radiotherapy, or surgery related to esophageal cancer. 5) Patients diagnosed with stages II-IVA (T1N2M0 or T2-T4bN0-2M0 or TanyN3M0) according to the AJCC (8th edition) staging system. 6) At least one measurable lesion present at baseline as defined by RECIST 1.1 criteria. 7) Adequate organ and bone marrow function, defined as follows: - Hematology: Absolute neutrophil count (ANC) =1.5×10^9/L; platelet count (PLT) =80×10^9/L; hemoglobin (HGB) =8.0 g/dL. - Hepatic function: Serum total bilirubin (TBIL) =1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN. - Renal function: Creatinine clearance (Ccr) =30 mL/min (calculated using the Cockcroft/Gault formula). - Coagulation function adequate, defined as international normalized ratio (INR) or prothrombin time (PT) =1.5×ULN; if the subject is on anticoagulant therapy, as long as the PT is within the range specified for the anticoagulant medication. 8) Life expectancy of more than 6 months. 9) No history of esophageal perforation, active esophageal bleeding, no obvious invasion of the trachea or major thoracic vessels, and no history of major thoracic vascular events. 10) Signed an informed consent form and is able to comply with the visits and related procedures as stipulated by the protocol.
Exclusion criteria
Exclusion criteria: 1) Patients with distant metastasis (except for supraclavicular or abdominal lymph node metastasis). Patients with multiple esophageal cancers. Patients with malignant pleural effusion or pericardial effusion. 2) History of prior radiotherapy, chemotherapy, or surgery for the primary tumor or lymph nodes. 3) Patients who have participated in another clinical trial within 30 days. 4) Presence of tracheoesophageal fistula, primary tumor invasion of the trachea or main bronchus, deep esophageal ulcer, or hematemesis before treatment. 5) History of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways. 6) Patients with severe cardiac, pulmonary, hepatic, renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that make them intolerant to chemotherapy. 7) Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planning to receive live attenuated vaccines during the study period. Note: Inactivated viral vaccines for seasonal influenza are allowed within 4 weeks prior to the first dose; however, live attenuated influenza vaccines are not permitted. 8) History of autoimmune disease requiring therapeutic intervention or a history of such disease within the past 2 years (vitiligo, psoriasis, alopecia, or Graves' disease that do not require systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement, and type 1 diabetes mellitus requiring only insulin replacement are allowed). 9) Known active pulmonary tuberculosis. 10) Active or poorly controlled severe infection. 11) Symptomatic congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled arrhythmias. 12) History of interstitial lung disease or non-infectious pneumonia. 13) Known acute or chronic active hepatitis B (HBsAg positive with HBV DNA viral load =103 copies/mL or >200 IU/mL) or acute or chronic active hepatitis C (HCV antibody positive with HCV RNA positive); positive for syphilis spirochete antibodies or human immunodeficiency virus antibodies. 14) History of other primary malignant tumors, except for: - Malignant tumors that have achieved complete remission for at least 2 years prior to enrollment and do not require additional treatment during the study; - Non-melanoma skin cancer or that have been adequately treated with no evidence of disease recurrence; - Carcinoma in situ that has been adequately treated with no evidence of disease recurrence. 15) Any mental or cognitive disorders that may limit understanding, execution of informed consent; any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;objective response rate (ORR);disease control rate (DCR);pathological complete response (PCR) rate of patients who received surgery;major pathological response (MPR) rate of patients who received surgery;R0 resection rate of patients who received surgery;progression-free survival (PFS);overall survival (OS); | — |
Countries
China
Contacts
Public ContactChao Cheng
The First Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed