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OncoMatch/Clinical Trials/NCT06569459

Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer

Is NCT06569459 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trilaciclib for esophageal cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06569459Data as of May 2026

Treatment: TrilaciclibThis study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage II, III, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anti-tumor therapy

Have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy, and other investigational therapeutic drugs)

Cannot have received: anti-PD-1 therapy

Have received or are receiving any of the following:Anti-PD-1 or anti-PD-L1 antibody therapy

Cannot have received: anti-PD-L1 therapy

Have received or are receiving any of the following:Anti-PD-1 or anti-PD-L1 antibody therapy

Cannot have received: chemotherapy

Have received or are receiving any of the following:...chemotherapy...

Cannot have received: radiotherapy

Have received or are receiving any of the following:...radiotherapy...

Cannot have received: targeted therapy

Have received or are receiving any of the following:...targeted therapy...

Cannot have received: investigational therapy

received any study drug within 4 weeks before the first dose of the study drug

Cannot have received: antitumor vaccine

Have received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of study drug

Cannot have received: live vaccine

Have received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of study drug

Cannot have received: hematopoietic stem cell or bone marrow transplantation

Prior hematopoietic stem cell or bone marrow transplantation

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥1.5×10^9/L;Platelet count ≥100×10^9/L;Hemoglobin ≥100 g/L in women or 110g/L in men;Serum albumin ≥2.8g/dL

Kidney function

serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min (according to Cockcroft - Gault formula)

Liver function

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

Vital organ function meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of screening examination) :Absolute neutrophil count (ANC) ≥1.5×10^9/L;Platelet count ≥100×10^9/L;Hemoglobin ≥100 g/L in women or 110g/L in men;Serum albumin ≥2.8g/dL;Total bilirubin ≤1.5 × ULN and ALT, AST, and/or AKP≤2.5 × ULN, serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min (according to Cockcroft - Gault formula)

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

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