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Esophageal Squamous Cell Carcinoma (ESCC)Phase 2ANCRENCT07595770

Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

A Phase 2 study testing • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
22 May 2026to 1 Oct 2029
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

  • - 1. Provided informed consent and sign the informed consent form;
  • 2. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
  • 3. Pathological confirmed ESCC;
  • 4. Patients assessed by thoracic oncologists as resectable without distant metastasis
  • 5. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;
  • 6. Have at least one assessable lesion according to the RECIST V1.1
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  • 7. ECOG-PS score: 0-1;
  • 8. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;
  • 9. With a life expectancy of ≥ 6 weeks;
  • 10. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;

Who cannot join

  • 1. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy
  • 2. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons
  • 3. Simultaneously developing tumors in other parts of the body
  • 4. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)
  • 5. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses>10 mg/day or oral prednisone for more than 2 weeks
  • 6. Severe allergy to immune preparations
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  • 7. Abnormal coagulation function: (PT>16s, APTT>53s, TT>21s, Fib<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy
  • 8. Pregnancy or lactation period
  • 9. Other situations as judged by investigators not suitable for inclusion.;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Baisheng Chen, M.D, PhD contact

+86-13560471611

Pason06213367@163.com

China1 site, 1 recruiting

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

    Baisheng Chen Chen, +86-13560471611, Pason06213367@163.com

    Recruiting

Other trials in China

About this study

Official title: A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma

This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.

Read the detailed description

CROSS Study showed that the pathological complete response (pCR) rate of patients with esophageal cancer (23% of whom were esophageal squamous cell carcinoma, ESCC) after neoadjuvant radiotherapy and chemotherapy was 29%. NEOCRTEC5010 Study showed that the pCR rate was 43.2% in locally advanced esophageal squamous cell carcinoma, which means that more than half of patients still cannot achieve ideal therapeutic effects from existing treatment options. In addition, the recurrence rate after surgical resection compromises the long-term survival rate of patients. Therefore, exploring new treatment strategies to improve the treatment efficacy and survival rate of esophageal cancer patients has important clinical significance. Currently, the significance of immunotherapy combined with chemoradiotherapy in terms of pathological complete response (pCR) rates and postoperative survival quality for locally advanced esophageal squamous cell carcinoma remains unclear. Therefore, this study aims to systematically evaluate the safety and efficacy of adebrelimab in combination with paclitaxel, carboplatin, and short-course radiotherapy as neoadjuvant therapy for ESCC. By integrating immunotherapy with existing standard treatment regimens, this study seeks to significantly improve pCR rates, optimize surgical resection outcomes, ultimately prolong disease-free survival (DFS), and enhance overall survival (OS). The implementation of this study is expected to provide innovative approaches and methods for the clinical treatment of ESCC, holding important clinical application value and significance.

Being tested
• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
Keywords
chemotherapy, radiotherapy, immune checkpoint inhibitors, adebrelimab
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.

  • • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapyDrug

    Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.

Study groups in NCT07595770
Study groupRoleWhat they receive
Adebrelimab and nab-paclitaxel plus carboplatin followed by radiotherapyExperimentalPatients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.
Receives: Drug: • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR)

    The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes; that is, the proportion of patients who have achieved complete remission among PPS(Per-Protocol Set).

    Measured: From patient enrollment to the end of surgery

Secondary outcomes (7)

  1. R0 resection rate

    The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.

    Measured: From patient enrollment to the end of surgery

  2. Disease free survival (DFS)

    Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.

    Measured: up to 24 months post-surgery

  3. Overall survival (OS)

    OS is the time interval from the start of treatment to death due to any reason or loss of follow-up

    Measured: up to 24 months after surgery

  4. Major pathological remission (MPR)

    Major pathological remission (MPR) refers to the percentage of residual tumor cells in the tumor bed after neoadjuvant therapy being ≤ 10%, regardless of whether there are residual tumor cells in the lymph nodes.

    Measured: From patient enrollment to the end of surgery

  5. Progression free survival (PFS)

    PFS is defined as the time from the start of treatment to the date of first documentation of disease progression, or date of death, whichever occurred first.

    Measured: Up to 24 months post-surgery

  6. Event free survival (EFS)

    EFS refers to the time from the start of treatment to the occurrence of any event, including disease progression, cessation of treatment for any reason, or death.

    Measured: From patient enrollment to the end of surgery

  7. Adverse Events

    Number of adverse events. The evaluation criteria for adverse reactions are based on the American Cancer Institute Common Adverse Event Terminology 4.0 (CTCAE 5.0) and the Acute Radiation Injury Grading Standards of the American Oncology Radiotherapy Collaboration Group (RTOG).

    Measured: from the first drug administration to within 30 days for the last Adebrelimab dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start22 May 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595770
Sponsor's protocol ID
SYSKY-2025-799-02
Acronym
ANCRE
Status last verified
May 2026
First submitted
13 May 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 10 inclusion and 9 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 19 May 2026. 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 Baisheng Chen, M.D, PhD (+86-13560471611, Pason06213367@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) (time frame: From patient enrollment to the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07595770.

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 19 May 2026.

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