Resectable Locally Advanced Thoracic Esophageal Squamous Cell CarcinomaPhase 2NCT07263919
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)
A Phase 2 study testing Cadonilimab (AK104), Cisplatin and Paclitaxel in people with Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, run by Akeso at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- What is being tested?
- Cadonilimab (AK104), Cisplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an
Xiaolong Yan, 15991269383, 47260934@qq.com
About this study
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)
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.
- Being tested
- Cadonilimab (AK104), Cisplatin, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab (AK104)Drug
Specified doses on specified days.
CisplatinDrug
IV infusion; 75mg/m2
PaclitaxelDrug
IV infusion; 175mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel | Experimental | Not described Receives: Drug: Cadonilimab (AK104); Drug: Cisplatin; Drug: Paclitaxel |
| Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel | Experimental | Not described Receives: Drug: Cadonilimab (AK104); Drug: Cisplatin; Drug: Paclitaxel |
| Cisplatin and Paclitaxel | Active comparator | Not described Receives: Drug: Cisplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 5 years
Secondary outcomes (9)
Major Pathological Response (MPR) rate as assessed by the investigator
Proportion of subjects with ≤10% residual live tumor cells as assessed by the investigator.
Measured: Up to approximately 2 years
R0 resection rate
Proportion of subjects with pathologically complete resection of primary tumors
Measured: 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.
Measured: Up to approximately 5 years
Disease Free Survival (DFS)
Time from surgery to local or distant recurrence, or death due to any cause.
Measured: Up to approximately 5 years
Overall Survival (OS)
Time from randomization until death from any cause.
Measured: Up to approximately 5 years
Overall Response Rate (ORR)
Proportion of subjects with complete response (CR) or partial response (PR) during the neoadjuvant stage.
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Evaluation of DCR based on RECIST v1.1
Measured: Up to approximately 2 years
Pharmacokinetics (PK)
PK parameters: serum concentrations of Cadonilimab at different point of time
Measured: Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
Proportion of subjects with detectable ADA.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start19 Dec 2025
- Primary completionMar 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Locally Advanced Thoracic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaolong Yan, Principal investigator, The Second Affiliated Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263919
- Sponsor's protocol ID
- AK104-312
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07263919
- Acronym / sponsor ID
- AK104-312
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadonilimab (AK104)Specified doses on specified days. | Drug | Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel, Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel |
| CisplatinIV infusion; 75mg/m2 | Drug | Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel, Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel, Cisplatin and Paclitaxel |
| PaclitaxelIV infusion; 175mg/m2 | Drug | Cadonilimab (dose 1) combined with Cisplatin and Paclitaxel, Cadonilimab (dose 2) combined with Cisplatin and Paclitaxel, Cisplatin and Paclitaxel |
Primary outcome
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.
9 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaolong Yan principal investigator
The Second Affiliated Hospital of Air Force Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab (AK104), Cisplatin and Paclitaxel in people with Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) rate as assessed by the investigator (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.