RecruitingPhase 1Phase 2NCT07385001

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

Enrollment

45 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer treatments — ivonescimab (a dual immunotherapy drug), albumin-paclitaxel (chemotherapy), and cisplatin (chemotherapy) — given before surgery to patients with esophageal squamous cell carcinoma (a cancer of the food pipe). The goal is to shrink the tumor before surgery to improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with resectable (operable) esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is locally advanced but has not spread to distant organs - You have good overall health (ECOG score 0–1) with adequate organ function - You are expected to survive at least 3 months and be able to undergo surgery **You may NOT be eligible if...** - You have received any prior cancer treatment - Your cancer has spread to the neck lymph nodes outside the upper chest area, or to distant organs - You have abnormal thyroid function (with certain exceptions) - You do not meet the blood count, liver, or kidney function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAK112

Cohort 1- AK112 10 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients

DRUGAK112

Cohort 2- AK112 dose of 20 mg/kg, every 3 weeks (Q3W), administered intravenously on day 1. Treatment will begin with the first patient. If the first patient does not experience any treatment-related safety issues, at least 24 hours will pass before the next 2 or 3 patients are treated.The dosing regimen and interval will remain unchanged for all patients

DRUGAK112 + Neoadjuvant chemotherapy

Neoadjuvant chemotherapy: Albumin-paclitaxel 130 mg/m², intravenous infusion on days 1 and 8, every 3 weeks (Q3W), total of 3 cycles Carboplatin with an area under the curve (AUC) of 5 mg/ml/min, intravenous infusion on day 1, every 3 weeks (Q3W), total of 3 cycles AK112: Based on the data collected during the dose-escalation phase 1b


Locations(1)

Tangdu Hospitial

Xi'an, Shannxi, China

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NCT07385001


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