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Clinical Trial NCT07263919 for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) Phase 2 90 Randomized Multi-Center

Recruiting
Clinical Trial NCT07263919 is designed to study Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma. It is a Phase 2 interventional study that is recruiting, having started on December 19, 2025, with plans to enroll 90 participants. Led by Akeso, it is expected to complete by December 1, 2031. The latest data from ClinicalTrials.gov was last updated on December 31, 2025.
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 resectab...Show More
Official Title

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)

Conditions
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Other Study IDs
  • AK104-312
NCT ID Number
NCT07263919
Start Date (Actual)
2025-12-19
Last Update Posted
2025-12-31
Completion Date (Estimated)
2031-12
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCadonilimab (dose 1) combined with Cisplatin and Paclitaxel
Cadonilimab (AK104)
Specified doses on specified days.
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
ExperimentalCadonilimab (dose 2) combined with Cisplatin and Paclitaxel
Cadonilimab (AK104)
Specified doses on specified days.
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Active ComparatorCisplatin and Paclitaxel
Cisplatin
IV infusion; 75mg/m2
Paclitaxel
IV infusion; 175mg/m2
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Major Pathological Response (MPR) rate as assessed by the investigator
Proportion of subjects with ≤10% residual live tumor cells as assessed by the investigator.
Up to approximately 2 years
R0 resection rate
Proportion of subjects with pathologically complete resection of primary tumors
Up to approximately 2 years
Event Free Survival (EFS)
Time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Up to approximately 5 years
Disease Free Survival (DFS)
Time from surgery to local or distant recurrence, or death due to any cause.
Up to approximately 5 years
Overall Survival (OS)
Time from randomization until death from any cause.
Up to approximately 5 years
Overall Response Rate (ORR)
Proportion of subjects with complete response (CR) or partial response (PR) during the neoadjuvant stage.
Up to approximately 2 years
Disease Control Rate (DCR)
Evaluation of DCR based on RECIST v1.1
Up to approximately 2 years
Pharmacokinetics (PK)
PK parameters: serum concentrations of Cadonilimab at different point of time
Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
Proportion of subjects with detectable ADA.
Up to approximately 2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
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Study Central Contact
Contact: Wenting Li, 18116403289, [email protected]
1 Study Locations in 1 Countries
The Second Affiliated Hospital of Air Force Medical University, Xi'an, China
Xiaolong Yan, Contact, 15991269383, [email protected]
Recruiting