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OncoMatch/Clinical Trials/NCT07162506

DCRT vs. Surgery in Resectable ESCC Patient Achiving cCR/PR After nCI

Is NCT07162506 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemotherapy for esophageal cancer.

Phase 2RecruitingTianjin Medical University Cancer Institute and HospitalNCT07162506Data as of May 2026

Treatment: ChemotherapyThis is a single-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant camrelizumab combined with chemotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of induction chemoimmunotherapy (camrelizumab + nab-paclitaxel + carboplatin) will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage II, III, IVA (8th AJCC)

clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-1 therapy (camrelizumab) — neoadjuvant

achieve cCR/PR after 2 cycles of camrelizumab combined with nab-paclitaxel and carboplatin

Must have received: taxane (nab-paclitaxel) — neoadjuvant

achieve cCR/PR after 2 cycles of camrelizumab combined with nab-paclitaxel and carboplatin

Must have received: platinum-based chemotherapy (carboplatin) — neoadjuvant

achieve cCR/PR after 2 cycles of camrelizumab combined with nab-paclitaxel and carboplatin

Cannot have received: anti-PD-1 therapy

Exception: except for camrelizumab

Anti-PD-1 (except for camrelizumab) or anti-PD-L1 antibody therapy

Cannot have received: anti-PD-L1 therapy

Anti-PD-1 (except for camrelizumab) or anti-PD-L1 antibody therapy

Cannot have received: chemotherapy

chemotherapy

Cannot have received: radiation therapy

radiotherapy

Cannot have received: targeted therapy

targeted therapy

Lab requirements

Blood counts

ANC ≥ 1.5×10^9/L; Platelets ≥ 80×10^9/L; Hemoglobin ≥ 9g/dL; Serum albumin ≥ 2.8g/dL; INR and APTT ≤ 1.5× ULN (subjects on stable anticoagulation therapy with INR within expected therapeutic range can be screened)

Kidney function

Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min

Liver function

Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN

The function of major organs meets the following requirements: ... see full criteria

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

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