A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclit… (NCT07385001) | Clinical Trial Compass
RecruitingPhase 1/2
A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC
China45 participantsStarted 2026-01-28
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Informed Consent: Written informed consent must be obtained before any study-related procedures are initiated.
* Age and Gender: Participants must be between 18 and 75 years of age, inclusive of both 18 and 75 years, and may be either male or female.
* Diagnosis and Stage: Participants must be histologically confirmed to have 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).
* Lymph Node Status: No suspicious lymph nodes in the neck region (excluding lymph nodes in the upper thoracic esophageal area) as per neck ultrasound or enhanced CT scan; no evidence of systemic metastasis on imaging.
* R0 Resectability: The participant is expected to achieve R0 resection.
* Measurable Lesion: At least one measurable tumor lesion must be present.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected Survival: The participant is expected to have a survival duration of at least 3 months.
* Thyroid Function: Normal thyroid function is defined as a thyroid-stimulating hormone (TSH) level within the normal range. Participants with baseline TSH levels outside the normal range may still be eligible if total T3 (or free T3) and free T4 levels are within the normal range.
* Organ Function: Laboratory results must meet the following criteria:
Hematology (no blood transfusion or blood component or granu…