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

NCT07263919 | Recruiting Phase 2

• 1 other identifier: AK104-312
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Pathologic Complete Response (pCR) rate as assessed by the investigator

  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)

  Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.

  Up to approximately 5 years

Secondary Outcomes (9)

• Major Pathological Response (MPR) rate as assessed by the investigator

  Up to approximately 2 years

• R0 resection rate

  Up to approximately 2 years

• Event Free Survival (EFS)

  Up to approximately 5 years

• Disease Free Survival (DFS)

  Up to approximately 5 years

• Overall Survival (OS)

  Up to approximately 5 years

Study Arms (3)

Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel

EXPERIMENTAL

Drug: Cadonilimab (AK104); Drug: Cisplatin; Drug: Paclitaxel

Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel

EXPERIMENTAL

Drug: Cadonilimab (AK104); Drug: Cisplatin; Drug: Paclitaxel

Cisplatin and Paclitaxel

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: Paclitaxel

Interventions

Cisplatin DRUG

IV infusion; 75mg/m2

Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel; Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel; Cisplatin and Paclitaxel

Cadonilimab (AK104) DRUG

Specified doses on specified days.

Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel; Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel

Paclitaxel DRUG

IV infusion; 175mg/m2

Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel; Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel; Cisplatin and Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The Second Affiliated Hospital of Air Force Medical University

Xi'an, China

RECRUITING

MeSH Terms

Interventions

Cisplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiaolong Yan

  The Second Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenting Li

CONTACT

18116403289; wenting01.li@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)