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Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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)

NCT07263919•Akeso

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+18 more criteria

Locations (1)

The Second Affiliated Hospital of Air Force Medical University

Xi'an, China

Key Dates

Start Date

December 19, 2025

Primary Completion Date

March 1, 2030

Completion Date

December 1, 2031

Last Updated

December 31, 2025

Enrollment

ESTIMATED participants

Conditions

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Interventions

Cadonilimab (AK104)

DRUG

Cisplatin

DRUG

Paclitaxel

DRUG

Contacts

Wenting Li

CONTACT

18116403289 wenting01.li@akesobio.com