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

Recruiting now · Phase 2

Conditions studied: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT07263919

Run by

Akeso

People needed

90

Starts

2025-12-19

Expected to finish

2031-12-01

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Second Affiliated Hospital of Air Force Medical University — Xi'an, China (enrolling)

Full record on ClinicalTrials.gov

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