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NCT07385001PHASE1, PHASE2RECRUITING

A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for ESCC

Phase Ib/II Trial of Atezolizumab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as Neoadjuvant Therapy for Resectable, Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor: Tang-Du Hospital

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Esophageal Squamous Cell Carcinoma, Ivonescimab, Neoadjuvant
Interventions
AK112, AK112, AK112 + Neoadjuvant chemotherapy
Enrollment
45 participants
Primary completion
Jan 2027
Study completion
Jan 2028
First posted
Feb 2026
Last updated
Feb 2026

Primary Endpoints (CT.gov)

DLT

Time frame: 1 year

Incidence and Severity of Adverse Events

Time frame: 1 year

MTD

Time frame: 1 year

RP2D

Time frame: 1 year

Secondary Endpoints

Objective response rate (ORR) by RECIST v1.1

Event-Free Survival (EFS)

Total survival time (OS)

Eligibility Criteria

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 Sur

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov