Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
NCT ID: NCT07263919
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-12-19
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Cadonilimab (AK104)
Specified doses on specified days.
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Cadonilimab (AK104)
Specified doses on specified days.
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Cisplatin and Paclitaxel
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Interventions
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Cadonilimab (AK104)
Specified doses on specified days.
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaolong Yan
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Air Force Medical University
Locations
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The Second Affiliated Hospital of Air Force Medical University
Xi'an, , China
Countries
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Central Contacts
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Facility Contacts
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Xiaolong Yan
Role: primary
Other Identifiers
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AK104-312
Identifier Type: -
Identifier Source: org_study_id