Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)

December 24, 2025 updated by: Akeso

A Randomized, Controlled, Multi-center Phase II/III Clinical Trial of Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (ESCC)

This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable ESCC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Xi'an, China
        • Recruiting
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
  • ≥18 years old and ≤ 75 years (regardless of sex).
  • Pathologically confirmed esophageal squamous cell carcinoma, assessed as resectable.
  • Adequate pulmonary function.
  • Adequate tumor tissue samples.
  • ECOG performance status of 0-1.
  • Adequate organ function.
  • Within 7 days prior to the first dose, women of childbearing potential must have a negative urine or serum pregnancy test and agree to use effective contraception during the study treatment period and for 120 days after the last dose.

Exclusion Criteria:

  • Presence of suspected distant metastatic lesions, or locally advanced unresectable disease.
  • Histologically confirmed as other pathological types.
  • Previous surgery precludes the use of gastric substitution for esophageal reconstruction in the current procedure.
  • History of other malignant tumors within the past 5 years.
  • Within 4 weeks prior to randomization, presence of conditions such as severe esophagogastric varices, active ulcers, unhealed wounds, gastrointestinal perforation, or intestinal obstruction.
  • Active or documented history of inflammatory bowel disease.
  • Clinically symptomatic or recurrent pleural, pericardial, or ascitic fluid requiring drainage.
  • Uncontrolled concurrent illnesses.
  • Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to randomization.
  • History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Arterial thromboembolic events within 6 months prior to randomization.
  • History or current presence of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoids.
  • Known psychiatric disorders, drug abuse, or substance addiction.
  • Pregnant or lactating women.
  • Prior systemic or local antitumor therapy for locally advanced esophageal squamous cell carcinoma.
  • Systemic non-specific immunomodulatory therapy within 2 weeks prior to randomization.
  • Major surgery or severe trauma within 4 weeks prior to randomization.
  • Known allergy to any component of the investigational drug(s).
  • Active autoimmune disease requiring systemic treatment within 2 years prior to randomization.
  • Active hepatitis B infection.
  • Known active tuberculosis.
  • Severe infections within 4 weeks prior to randomization.
  • History of immunodeficiency or positive HIV test.
  • Known active syphilis infection.
  • Live vaccination within 4 weeks prior to randomization or planned during the study.
  • History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • Is currently participating in a study of an investigational agent or using an investigational device.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Drug: Cadonilimab (AK104)
Specified doses on specified days.
Drug: Cisplatin
IV infusion; 75mg/m2
Drug: Paclitaxel
IV infusion; 175mg/m2
Experimental: Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Drug: Cadonilimab (AK104)
Specified doses on specified days.
Drug: Cisplatin
IV infusion; 75mg/m2
Drug: Paclitaxel
IV infusion; 175mg/m2
Active Comparator: Cisplatin and Paclitaxel
Drug: Cisplatin
IV infusion; 75mg/m2
Drug: Paclitaxel
IV infusion; 175mg/m2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathologic Complete Response (pCR) rate as assessed by the investigator
Time Frame: Up to approximately 2 years
Proportion of subjects with no tumor residue in the primary tumor and regional lymph nodes.
Up to approximately 2 years
Adverse Event (Phase II stage)
Time Frame: Up to approximately 5 years
Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.
Up to approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: Up to approximately 2 years
Proportion of subjects with pathologically complete resection of primary tumors
Up to approximately 2 years
Major Pathological Response (MPR) rate as assessed by the investigator
Time Frame: Up to approximately 2 years
Proportion of subjects with ≤10% residual live tumor cells as assessed by the investigator.
Up to approximately 2 years
Event Free Survival (EFS)
Time Frame: Up to approximately 5 years
Time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Up to approximately 5 years
Disease Free Survival (DFS)
Time Frame: Up to approximately 5 years
Time from surgery to local or distant recurrence, or death due to any cause.
Up to approximately 5 years
Overall Survival (OS)
Time Frame: Up to approximately 5 years
Time from randomization until death from any cause.
Up to approximately 5 years
Overall Response Rate (ORR)
Time Frame: Up to approximately 2 years
Proportion of subjects with complete response (CR) or partial response (PR) during the neoadjuvant stage.
Up to approximately 2 years
Disease Control Rate (DCR)
Time Frame: Up to approximately 2 years
Evaluation of DCR based on RECIST v1.1
Up to approximately 2 years
Pharmacokinetics (PK)
Time Frame: Up to approximately 2 years
PK parameters: serum concentrations of Cadonilimab at different point of time
Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
Time Frame: Up to approximately 2 years
Proportion of subjects with detectable ADA.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akeso

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaolong Yan, The Second Affiliated Hospital of Air Force Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK104-312

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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