---
title: Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
nct_id: NCT07263919
overall_status: RECRUITING
phase: PHASE2
sponsor: Akeso
study_type: INTERVENTIONAL
primary_condition: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07263919.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07263919"
ct_last_update_post_date: 2025-12-31
last_seen_at: "2026-05-12T07:17:09.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)

**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)

**NCT ID:** [NCT07263919](https://clinicaltrials.gov/study/NCT07263919)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Akeso
- **Conditions:** Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- **Start Date:** 2025-12-19
- **Completion Date:** 2031-12
- **CT.gov Last Update:** 2025-12-31

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
* 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.
```

## Arms

- **Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel** (EXPERIMENTAL)
- **Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel** (EXPERIMENTAL)
- **Cisplatin and Paclitaxel** (ACTIVE_COMPARATOR)

## Interventions

- **Cadonilimab (AK104)** (DRUG) — Specified doses on specified days.
- **Cisplatin** (DRUG) — IV infusion; 75mg/m2
- **Paclitaxel** (DRUG) — IV infusion; 175mg/m2

## Primary Outcomes

- **Pathologic Complete Response (pCR) rate as assessed by the investigator** _(time frame: Up to approximately 2 years)_ — Proportion of subjects with no tumor residue in the primary tumor and regional lymph nodes.
- **Adverse Event (Phase II stage)** _(time frame: Up to approximately 5 years)_ — Incidence and severity of adverse events (AEs), rate of delayed surgery, and clinically significant abnormal laboratory findings.

## Secondary Outcomes

- **Major Pathological Response (MPR) rate as assessed by the investigator** _(time frame: Up to approximately 2 years)_
- **R0 resection rate** _(time frame: Up to approximately 2 years)_
- **Event Free Survival (EFS)** _(time frame: Up to approximately 5 years)_
- **Disease Free Survival (DFS)** _(time frame: Up to approximately 5 years)_
- **Overall Survival (OS)** _(time frame: Up to approximately 5 years)_
- **Overall Response Rate (ORR)** _(time frame: Up to approximately 2 years)_
- **Disease Control Rate (DCR)** _(time frame: Up to approximately 2 years)_
- **Pharmacokinetics (PK)** _(time frame: Up to approximately 2 years)_
- **Anti-Drug Antibodies(ADAs)** _(time frame: Up to approximately 2 years)_

## Locations (1)

- The Second Affiliated Hospital of Air Force Medical University, Xi'an, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the second affiliated hospital of air force medical university|xi'an||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07263919.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07263919*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*