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Esophageal CancerPhase 2NCT07780721

Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer

A Phase 2 study testing Adebrelimab, Thymalfasin and Chemotherapy in people with Esophageal Cancer, run by The Affiliated Hospital of Putian University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Adebrelimab, Thymalfasin and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
30 Aug 2026to 1 Feb 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has signed the written informed consent form and voluntarily participates in this study;
  • Aged 18-80 years, male or female;
  • Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;
  • Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;
  • Has at least one measurable lesion (per RECIST Version 1.1: the measurable lesion has a longest diameter ≥10 mm on spiral CT scan, or a malignant lymph node with short-axis diameter ≥15 mm);
  • Expected to achieve R0 resection;
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  • ECOG Performance Status (PS) 0-1 (see Appendix 1);
  • Has not received any prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;
  • Plans to receive surgical resection after completion of neoadjuvant therapy;
  • No contraindications to surgery.
  • Adequate organ function as specified below:
  • Hematology laboratory values (No blood products, hematopoietic growth factors, leukopoietic agents, thrombopoietic agents or anti-anemia medications are permitted within 14 days prior to the first study drug administration):
  • White blood cell count ≥ 3.0 × 10⁹/L Absolute neutrophil count ≥ 1.0 × 10⁹/L Platelet count ≥ 80 × 10⁹/L Hemoglobin ≥ 90 g/L
  • Serum chemistry:
  • Total bilirubin ≤ 1.5 × ULN Alanine transaminase (ALT) ≤ 2.5 × ULN; Aspartate transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula, see Appendix 2)
  • Coagulation function:
  • International normalized ratio (INR) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
  • Female subjects of reproductive potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug, and must use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for at least 3 months after the last dose of study drug. Male subjects with female partners of reproductive potential must use effective contraception throughout the study and for 3 months after the last dose.
  • Subjects with good compliance and willingness to complete follow-up visits.

Who cannot join

  • Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
  • Poor nutritional status with BMI < 18.5 kg/m². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator;
  • History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;
  • Previously received or currently receiving any of the following treatments:
  • Any anti-tumor radiotherapy, chemotherapy, immunotherapy, targeted therapy or other anti-neoplastic agents;
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  • Immunosuppressive agents or systemic corticosteroids administered for immunosuppressive purposes (prednisone >10 mg/day or equivalent dose) within 2 weeks prior to the first study drug administration. Inhaled or topical steroids, and corticosteroid replacement therapy (prednisone >10 mg/day or equivalent dose) are permitted in the absence of active autoimmune disease;
  • Live attenuated vaccines administered within 4 weeks prior to the first study drug administration;
  • Major surgery or severe trauma within 4 weeks prior to the first study drug administration.
  • Active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects receiving hormone replacement therapy may be enrolled). Subjects with psoriasis or childhood asthma/allergies completely resolved without any intervention in adulthood can be considered eligible; patients requiring medical intervention with bronchodilators are excluded.
  • History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, history of solid organ transplantation or allogeneic bone marrow transplantation;
  • Poorly controlled cardiac signs or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after intervention.
  • Severe infection (CTCAE Grade >2) within 4 weeks before the first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Active pulmonary inflammation indicated by baseline chest imaging; subjects presenting with signs and symptoms of infection within 14 days before first dosing or requiring oral/intravenous antibiotics, except for prophylactic antibiotic use.
  • Active pulmonary tuberculosis confirmed by medical history or CT scan; history of active pulmonary tuberculosis within 1 year before enrollment; or history of active pulmonary tuberculosis more than 1 year previously without standardized treatment.
  • Hereditary bleeding diathesis or coagulation disorders. Clinically significant bleeding events or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++.
  • Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival rate >90%). Fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of cervix, etc., may be considered for enrollment.
  • Pregnant or breastfeeding women.
  • Any other conditions judged by the investigator that may force premature study discontinuation, such as other severe diseases (including psychiatric disorders) requiring combined medication, alcohol abuse, drug abuse, family or social factors that may affect subject safety or compliance.

Trial locations and contacts

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

guozhong Huang, Bachelor's Degree contact

13959560301

13959560301@163.com

China1 site

  • Affiliated Hospital of Putian University

    Putian, Fujian, 351100

    guozhong Huang, Bachelor, 13959560301, 13959560301@163.com

Other trials in China

About this study

Official title: Exploratory, Single-Arm, Multicenter Clinical Study of Adebrelimab Combined With Thymalfasin and Chemotherapy as Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.

Being tested
Adebrelimab, Thymalfasin, Chemotherapy
Keywords
Chemotherapy, Adebrelimab, neoadjuvant treatment, Esophageal Cancer
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdebrelimabDrug

    Adebrelimab: 1200 mg, intravenous infusion on Day 1, every 3 weeks (Q3W)

  • ThymalfasinDrug

    Thymalfasin: 1.6 mg, subcutaneous injection twice weekly for every 3-week cycle.

  • ChemotherapyDrug

    Nab-paclitaxel: 260 mg/m², intravenous infusion on Day 1, every 3 weeks (Q3W); Cisplatin: 75 mg/m², intravenous infusion on Day 1 / Day 2 / Day 3, every 3 weeks (Q3W); OR Carboplatin: AUC = 5-6, intravenous infusion on Day 1, every 3 weeks (Q3W).

Study groups in NCT07780721
Study groupRoleWhat they receive
Treatment Arm (Adebrelimab + Thymalfasin + Chemotherapy Neoadjuvant Regimen)ExperimentalAll eligible patients receive neoadjuvant therapy for 2-3 cycles (3 weeks per cycle), followed by radical esophagectomy with lymph node dissection.
Receives: Drug: Adebrelimab; Drug: Thymalfasin; Drug: Chemotherapy

What is being measured

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

  1. Pathologic Complete Response (pCR) Rate

    Defined as the proportion of subjects with Grade I pathological response per the pathological response evaluation criteria after neoadjuvant therapy, i.e., no residual viable tumor in the primary tumor lesion.

    Measured: 2 weeks after surgery

Secondary outcomes (6)

  1. R0 Resection Rate

    No residual viable tumor cells at the surgical resection margins

    Measured: 2 weeks after surgery

  2. Major Pathologic Response （MPR）Rate

    Defined as the percentage of subjects with ≤10% residual viable tumor (Grade I and Grade II pathological response).

    Measured: 2 weeks after surgery

  3. Disease-Free Survival(DFS)

    Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.

    Measured: Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.Assessed for a maximum of 60 months.

  4. Objective Response Rate(ORR）

    Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) based on imaging assessments performed from study enrollment to prior to surgery, evaluated per RECIST version 1.1 criteria.

    Measured: At the end of Cycle 2-3 (each cycle is 21 days)

  5. Overall Survival(OS)

    Defined as the time from the date of first study drug administration to death from any cause.

    Measured: From date of first study drug administration until death from any cause, assessed up to study completion。Assessed for a maximum of 60 months.

  6. Incidence and Grade of Adverse Events and Serious Adverse Events [Safety and Tolerability]

    Assessed according to NCI-CTCAE Version 5.0 criteria

    Measured: From informed consent signature through 90 days after the last dose of adebrelimab

Timeline

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

  1. First posted21 Aug 2026
  2. Study start30 Aug 2026 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Feb 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
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780721
Sponsor's protocol ID
2026161
Status last verified
Aug 2026
First submitted
3 Aug 2026
Last updated
21 Aug 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, Thymalfasin and Chemotherapy in people with Esophageal Cancer, run by The Affiliated Hospital of Putian 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 19 inclusion and 18 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: opening soon, as of the sponsor's last update on 21 Aug 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 guozhong Huang, Bachelor's Degree (13959560301, 13959560301@163.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 (time frame: 2 weeks after 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 NCT07780721.

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 21 Aug 2026.

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