Esophageal Squamous Cell CarcinomaPhase 2NCT07016724
Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
A Phase 2 study testing cadonilizumab combined with neoadjuvant radiochemotherapy and neoadjuvant radiochemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- cadonilizumab combined with neoadjuvant radiochemotherapy and neoadjuvant radiochemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Aug 2027
- 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
- diagnosed with esophageal squamous cell cancer;
- staged with cT1N+M0/cT2-3N0-3M0;
- experienced no cancer-related treatment;
- ECOG 0-1;
- Expected survival more than 6 months;
- aimed at neoadjuvant therapy for surger;
- have adquate organ function.
Who cannot join
- diagnosed with other types of cancer during last five years;
- have a tendency to bleed;
- accepted any type of cancer-related therapy.
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 First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Xiangbo Wan, Ph.D, 0086-037166271152, wanxbo@zzu.edu.cn
About this study
Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- cadonilizumab combined with neoadjuvant radiochemotherapy, neoadjuvant radiochemotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cadonilizumab combined with neoadjuvant radiochemotherapyCombination product
Also called neoadjuvant radiochemotherapy
Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.
neoadjuvant radiochemotherapyCombination product
Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy | Experimental | Subjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery. Receives: Combination Product: cadonilizumab combined with neoadjuvant radiochemotherapy |
| Arm 2: neoadjuvant radiochemotherapy | Placebo comparator | Subjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery. Receives: Combination Product: neoadjuvant radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathological complete response
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Aug 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangbo Wan, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Xiangbo Wan, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016724
- Sponsor's protocol ID
- TA2024-404-ESCC
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT07016724
- Acronym / sponsor ID
- TA2024-404-ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Jun 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.
Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy | Experimental | Combination Product: cadonilizumab combined with neoadjuvant radiochemotherapySubjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery. |
| Arm 2: neoadjuvant radiochemotherapy | Placebo comparator | Combination Product: neoadjuvant radiochemotherapySubjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with esophageal squamous cell cancer;
- staged with cT1N+M0/cT2-3N0-3M0;
- experienced no cancer-related treatment;
- ECOG 0-1;
- Expected survival more than 6 months;
Key exclusion criteria (3 listed)
- diagnosed with other types of cancer during last five years;
- have a tendency to bleed;
- accepted any type of cancer-related therapy.
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 |
|---|---|---|
| cadonilizumab combined with neoadjuvant radiochemotherapyAlso: neoadjuvant radiochemotherapySubjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery. | Combination product | Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy |
| neoadjuvant radiochemotherapySubjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy. | Combination product | Arm 2: neoadjuvant radiochemotherapy |
Primary outcome
pCR
Time frame: perioperative
pathological complete response
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 12 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Xiangbo Wan principal investigator
The First Affiliated Hospital of Zhengzhou 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 cadonilizumab combined with neoadjuvant radiochemotherapy and neoadjuvant radiochemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University 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 7 inclusion and 3 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 12 Jun 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. Some participants in this study may receive a placebo. 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 Fuwei Wang (0086-037166278517, wanxbo@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: perioperative). 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 12 Jun 2025.