By InvitationPhase 2

Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma

China48 participantsStarted 2025-11-01

Plain-language summary

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Absolute neutrophil count ≥ 1.5 × 109, platelet count ≥ 80 × 109, hemoglobin count ≥ 90g/L;
✓. Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastases, AST and ALT levels ≤ 5 times ULN);
✓. Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft Gault formula);
✓. Serum albumin ≥ 28g/L;
✓. Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
✓. Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% normal value, percentage of measured and predicted DLCO (lung diffusion function)\>80%.

Exclusion criteria

✕. Patients with poor blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction;
✕. Active or uncontrolled severe infections;
✕. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method); 5. Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal bleeding during subsequent studies; 6. Pregnant or lactating women; Patients with other malignant tumors within 7.5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 8. Patients with a history of abuse of psychotropic drugs who cannot be quit or those with mental disorders; 9. Patients who have participated in clinical trials of other drugs within the past four weeks; 10. Patients with accompanying diseases that pose a serious threat to patient safety or affect the completion of the study, as determined by the researchers; 11.Researchers believe that it is not suitable for inclusion.

What they're measuring

Pathological complete response (pCR) rate

Timeframe: up to 2 years

Trial details

NCT IDNCT07312578

SponsorPeking University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials