OncoMatch/Clinical Trials/NCT06563869
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Is NCT06563869 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies PEG-rhG-GSF for esophageal squamous cell carcinoma.
Treatment: PEG-rhG-GSF — This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage II, III, IVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-programmed death-1 (PD-1) antibody
Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening
Cannot have received: anti-PD-L1 antibody
Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening
Cannot have received: anti-CTLA-4 antibody
Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening
Cannot have received: molecular targeted therapy
Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening
Cannot have received: surgery
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
Cannot have received: radiotherapy
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
Cannot have received: chemotherapy
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
Cannot have received: immunotherapy
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
Cannot have received: targeted therapy
Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.
Lab requirements
Blood counts
Hemoglobin HB ≥ 90 g/L; Absolute neutrophil count ANC ≥ 1.5 × 10^9 /L; Platelet count PLT ≥ 80 × 10^9 /L; Albumin ALB ≥ 35 g/L; Coagulation: PT-INR ≤ 2.3 or PT < 6 seconds compared with the normal control
Kidney function
Creatinine SCr ≤ the upper limit of the normal range
Liver function
ALT and AST ≤ 1.5 times the upper limit of the normal range; Total bilirubin ≤ 30 μmol/L
Cardiac function
adequate heart function
Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators: i. Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 10^9 /L iii. Platelet count PLT ≥ 80 × 10^9 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT < 6 seconds compared with the normal control
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify