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OncoMatch/Clinical Trials/NCT04280822

Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma

Is NCT04280822 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies Neoadjuvant immunochemotherapy for esophageal cancer.

Phase 3RecruitingHenan Cancer HospitalNCT04280822Data as of Jun 2026Location: China

Treatment: Neoadjuvant immunochemotherapyThe effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.

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Extracted eligibility criteria

Treatments studied

Other

Neoadjuvant immunochemotherapy

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage T1N1-3M0, T2-3N0-3M0 (8th Union for International Cancer Control, UICC-TNM)

Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anticancer therapy

Patients must not have received any prior anticancer therapy of esophageal carcinoma.

Lab requirements

Blood counts

white blood cells count ≥4.0×10^9/L, neutrophil ≥1.5×10^9/L, platelets ≥100.0×10^9/L, hemoglobin ≥90g/L

Kidney function

normal functions of kidney, endogenous creatinine clearance rate(CRE)≤1.5N

Liver function

normal functions of liver, total bilirubin(TBIL)≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N

Absolute white blood cells count ≥4.0×10^9/L, neutrophil ≥1.5×10^9/L, platelets ≥100.0×10^9/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin(TBIL)≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04280822 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage T1N1-3M0 or T2-3N0-3M0 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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