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Ivonescimab and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

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Study Aim

This study aims to evaluate the effectiveness of combining Ivonescimab and chemotherapy in achieving complete tumor removal in people with resectable esophageal squamous cell carcinoma.

What is being tested

Ivonescimab(AK112), Albumin paclitaxel, carboplatin AUC=5, neoadjuvant therapy

+ Esophagectomy

+ Sample

Combination ProductProcedureOther
Who is being recruted

Esophageal Squamous Cell Carcinoma+12

+ Carcinoma

+ Carcinoma, Squamous Cell

From 18 to 75 Years
1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactZixiang Wu, M.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2025

Actual date on which the first participant was enrolled.

This study is exploring a new treatment option for patients with esophageal squamous cell carcinoma, a type of cancer affecting the esophagus. In China, esophageal cancer is particularly common, and current treatments like surgery and chemotherapy have not significantly lowered the death rate. For patients whose cancer has spread locally but not extensively, surgery alone often isn't enough to remove all cancer cells or prevent the disease from coming back. This study focuses on combining a new drug called Ivonescimab, which is designed to help the immune system fight cancer, with chemotherapy before surgery. The goal is to see if this combination can improve survival rates by reducing the risk of cancer returning after surgery. Participants in this study will receive Ivonescimab along with chemotherapy before undergoing surgery. Ivonescimab is given as a treatment that targets specific proteins to help the body’s immune system better attack the cancer cells. The main goal of the study is to see if this treatment approach can completely eliminate the cancer cells in the tissue that is removed during surgery, known as a Pathological Complete Response. By measuring the absence of invasive tumor cells in the removed tissues, researchers hope to determine the effectiveness of the treatment. If successful, this study could lead to better treatment strategies for patients with this type of esophageal cancer.

Official TitleA Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Ivonescimab(AK112) Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Study ContactZixiang Wu, M.D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

49 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Esophageal Squamous Cell CarcinomaCarcinomaCarcinoma, Squamous CellDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms, Squamous Cell

Criteria

1 inclusion criteria required to participate
ECOG PS 0-1.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Preoperative neoadjuvant therapy for 3 cycles. Radical surgery is performed 4-8 weeks after the last dose. Postoperative radiotherapy is determined according to the clinical situation and pathological stage of the patient. Ivonescimab(AK112) can be maintained for a maximum of 1 year. During the study, patients were be followed until disease progression, withdrawal of informed consent, loss of follow-up, or death.

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Second Affiliated Hospital of Zhejiang University

Hangzhou, ChinaOpen The Second Affiliated Hospital of Zhejiang University in Google Maps
Recruiting soonOne Study Center