OncoMatch/Clinical Trials/NCT07385001
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
Is NCT07385001 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including AK112 and AK112 for esophageal squamous cell carcinoma.
Treatment: AK112 · AK112 · AK112 + Neoadjuvant chemotherapy — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined with Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage T1 N1-N3 M0, T2-T4A N0-N3 M0 (WITH T2 ≥ 2 CM OR POORLY DIFFERENTIATED)
resectable, locally advanced esophageal squamous cell carcinoma (ESCC) with the following criteria:-T1 N1-N3 M0 or T2-T4a N0-N3 M0 (with T2 ≥ 2 cm or poorly differentiated)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
Cannot have received: anti-PD-L1 therapy
Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
Cannot have received: checkpoint inhibitor (CTLA-4, OX-40)
Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
Cannot have received: anti-angiogenic agent (bevacizumab, endostar)
Prior Treatment with PD-1/PD-L1 Inhibitors or Other Immune-Modulating Drugs: Participants who have previously received treatment with PD-1/PD-L1 inhibitors or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40) or anti-angiogenic agents (e.g., bevacizumab, endostar) are excluded.
Cannot have received: systemic non-specific immune-modulating therapy (interleukins, interferons, thymopentin)
Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.
Cannot have received: traditional Chinese medicine or herbal preparations with anti-tumor indications
Participants who have received systemic non-specific immune-modulating therapy (e.g., interleukins, interferons, thymopentin) within 2 weeks prior to the first dose of study drug, or who have used traditional Chinese medicine or herbal preparations with anti-tumor indications within 2 weeks prior to the first dose, are excluded.
Lab requirements
Blood counts
Neutrophil count (NEU) ≥ 1.5 × 10⁹/L (1,500/mm³); Platelet count (PLT) ≥ 100 × 10⁹/L (100,000/mm³); Hemoglobin ≥ 90 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula)
Liver function
Total bilirubin (TBil) ≤ 1.5 × ULN; or for participants with TBil < 1.5 × ULN, direct bilirubin must be within the normal range; AST and ALT ≤ 2.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Laboratory results must meet the following criteria: Hematology (no blood transfusion or blood component or granulocyte colony-stimulating factor treatment within 14 days): Neutrophil count (NEU) ≥ 1.5 × 10⁹/L (1,500/mm³); Platelet count (PLT) ≥ 100 × 10⁹/L (100,000/mm³); Hemoglobin ≥ 90 g/L. Liver: Total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); or for participants with TBil < 1.5 × ULN, direct bilirubin must be within the normal range; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN. Renal: Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula). Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07385001 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy, checkpoint inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage T1 N1-N3 M0 or T2-T4A N0-N3 M0 (WITH T2 ≥ 2 CM OR POORLY DIFFERENTIATED) 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.
Check if I qualifyRelated pages