Perioperative cadonilimab plus neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled phase II/III multicenter trial compares perioperative cadonilimab combined with standard neoadjuvant cisplatin and paclitaxel chemotherapy versus neoadjuvant chemotherapy alone in adults with resectable locally advanced thoracic ESCC. Eligible patients (age 18–75, ECOG 0–1) must provide tumor tissue and have adequate organ and pulmonary function. Participants receive preoperative therapy followed by planned surgical resection, with monitoring for safety and efficacy endpoints such as pathological response and survival outcomes. The study is sponsored by Akeso and conducted at participating hospitals including The Second Affiliated Hospital of Air Force Medical University in Xi'an.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Xiaolong Yan — The Second Affiliated Hospital of Air Force Military Medical University
• Study coordinator: Wenting Li
• Email: wenting01.li@akesobio.com
• Phone: 18116403289

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.