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Esophageal Squamous Cell CarcinomaPhase 2NCT07452601

Time-of-Day of Immunotherapy Infusion in Neoadjuvant Immunochemotherapy for Thoracic ESCC

A Phase 2 study testing Adebrelimab plus nab-paclitaxel and cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Tang-Du Hospital 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
Search all trials

Trial summary

This is a prospective, multi-cohort, exploratory clinical study designed to evaluate the efficacy and safety of neoadjuvant adebrelimab combined with chemotherapy in patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), with a particular focus on the effect of the time-of-day of… 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?
Adebrelimab plus nab-paclitaxel and cisplatin
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
5 May 2026to 30 Dec 2028
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

  • Patients who have signed a written informed consent form and voluntarily agree to participate in the study.
  • Histologically or cytologically confirmed esophageal squamous cell carcinoma.
  • Tumor located in the thoracic esophagus, assessed by CT, MRI, EUS, or other imaging modalities, with clinical stage T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk features: lymphovascular invasion [LVI], tumor ≥3 cm, or poor differentiation) according to AJCC 8th edition.
  • Tumors deemed potentially resectable with R0 margins.
  • Age between 18 and 75 years, male or female.
  • ECOG performance status of 0 or 1.
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  • No prior anti-tumor treatment for esophageal cancer, including surgery, radiotherapy, or chemotherapy.
  • Planned to undergo surgery after completion of neoadjuvant therapy.
  • No contraindications to surgery.
  • Adequate organ function, including:
  • Hematologic parameters(no blood products, growth factors, erythropoiesis-stimulating agents, or platelet-stimulating drugs within 14 days prior to first study drug administration): Absolute neutrophil count ≥1.5 × 10⁹/L;Platelet count ≥100 × 10⁹/L;Hemoglobin ≥90 g/L.
  • Biochemical parameters:Total bilirubin ≤1.5 × ULN; ALT ≤2.5 × ULN, AST ≤2.5 × ULN;Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min.
  • Coagulation parameters:International normalized ratio (INR) ≤1.5 × ULN; Activated partial thromboplastin time (APTT) ≤1.5 × ULN.
  • For women of childbearing potential, a negative serum pregnancy test within 72 hours prior to first study drug administration and agreement to use effective contraception during the study and for at least 3 months after the last dose (e.g., intrauterine device, oral contraceptives, or condoms). Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the study and for at least 3 months after the last dose.
  • Good compliance and willingness to adhere to study procedures and follow-up. ---

Who cannot join

  • Tumor with obvious invasion of adjacent critical structures, such as the aorta or trachea.
  • Presence of supraclavicular lymph node metastasis.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Poor nutritional status with body mass index (BMI) <18.5 kg/m²; patients whose nutritional status is corrected before randomization through supportive care may be considered eligible at the discretion of the principal investigator.
  • Known hypersensitivity to monoclonal antibodies, adebrelimab, nab-paclitaxel, cisplatin, or other platinum-based agents.
  • Prior or ongoing treatments as follows:
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  • Any prior anti-tumor therapy, including chemotherapy, radiotherapy, or other anti-cancer drugs;
  • Use of systemic immunosuppressive therapy or corticosteroids for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration. Inhaled or local steroid use and corticosteroid replacement therapy >10 mg/day prednisone equivalent in patients without active autoimmune disease are permitted;
  • Administration of live attenuated vaccines within 4 weeks prior to first study drug administration;
  • Major surgery or severe trauma within 4 weeks prior to first study drug administration.
  • Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma/allergy fully resolved in adulthood and not requiring intervention may be eligible, but those requiring ongoing medical management with bronchodilators are excluded.
  • History of immunodeficiency, including positive HIV test, other congenital or acquired immunodeficiency, or history of organ or allogeneic bone marrow transplantation.
  • Uncontrolled clinically significant cardiac conditions, including but not limited to:
  • NYHA class II or higher heart failure;Unstable angina;Myocardial infarction within 1 year;Clinically significant supraventricular or ventricular arrhythmias inadequately controlled despite intervention.
  • Severe infection (CTCAE > grade 2) within 4 weeks prior to first study drug administration requiring hospitalization, including severe pneumonia, bacteremia, or infectious complications. Patients with active pulmonary inflammation on baseline imaging, infection symptoms within 14 days prior to first study drug administration, or requiring oral/IV antibiotics (excluding prophylactic antibiotics) are excluded.
  • Active pulmonary tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or history of untreated active tuberculosis more than 1 year prior to enrollment.
  • Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C infection (positive HCV antibody with HCV RNA above the assay detection limit).
  • Diagnosis of other malignancies within the past 5 years, except for tumors with low risk of metastasis or mortality (5-year survival >90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
  • Pregnant or breastfeeding women.
  • Any other condition that, in the opinion of the investigator, could lead to premature discontinuation of study treatment or compromise participant safety or compliance, including serious comorbidities (including psychiatric disorders requiring concomitant therapy), alcohol or substance abuse, or social/familial factors.

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

  • Tangdu Hospital Affiliated to the Fourth Military Medical University

    Xi'an, Shannxi, 710038

    Xiaolong Yan, Dr, 029-847171569, yanxiaolong@fmmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effect of Time-of-Day of Immunotherapy Infusion on Outcomes of Neoadjuvant Immunochemotherapy in Thoracic Esophageal Squamous Cell Carcinoma: A Prospective Cohort Study

This is a prospective, multi-cohort, exploratory clinical study designed to evaluate the efficacy and safety of neoadjuvant adebrelimab combined with chemotherapy in patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), with a particular focus on the effect of the time-of-day of immunotherapy infusion.

Eligible patients with histologically or cytologically confirmed, resectable locally advanced thoracic ESCC will be randomly assigned in a 1:1:1 ratio to three cohorts according to predefined immunotherapy infusion time windows. Cohort A will receive adebrelimab plus chemotherapy with the first cycle initiated at or after 15:00 and subsequent cycles initiated before 15:00; Cohort B will receive all three cycles initiated before 15:00; and Cohort C will receive all three cycles initiated at or after 15:00. Neoadjuvant treatment consists of three cycles of adebrelimab in combination with nab-paclitaxel and cisplatin, followed by surgical resection 4-6 weeks after completion of neoadjuvant therapy.

Read more

The primary endpoint of the study is pathological complete response (pCR). Secondary endpoints include event-free survival (EFS), major pathological response (MPR) rate, R0 resection rate, overall survival (OS), and disease-free survival (DFS).

Tumor response will be assessed according to RECIST version 1.1, and pathological response will be evaluated using the College of American Pathologists (CAP) tumor regression grading system and AJCC 8th edition staging criteria. Safety will be continuously monitored throughout the study, and patients will undergo scheduled follow-up for disease progression or recurrence and survival after completion of study treatment.

Being tested
Adebrelimab plus nab-paclitaxel and cisplatin
Keywords
ESCC, Time-of-Day, Neoadjuvant, 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 plus nab-paclitaxel and cisplatinDrug

    Patients receive neoadjuvant therapy with adebrelimab in combination with nab-paclitaxel and cisplatin for three 21-day cycles. Immunochemotherapy is administered intravenously according to the assigned cohort's immunotherapy infusion timing. Surgery is planned 4-6 weeks after completion of neoadjuvant therapy.

Study groups in NCT07452601
Study groupRoleWhat they receive
First Cycle After 15:00, Subsequent Cycles Before 15:00ExperimentalPatients receive neoadjuvant therapy with adebrelimab plus nab-paclitaxel and cisplatin for three cycles. The first cycle of immunotherapy plus chemotherapy is initiated at or after 15:00; the second and third cycles are initiated before 15:00.
Receives: Drug: Adebrelimab plus nab-paclitaxel and cisplatin
All Cycles Before 15:00ExperimentalPatients receive neoadjuvant therapy with adebrelimab plus nab-paclitaxel and cisplatin for three cycles. All three cycles of immunotherapy plus chemotherapy are initiated before 15:00.
Receives: Drug: Adebrelimab plus nab-paclitaxel and cisplatin
All Cycles After 15:00ExperimentalPatients receive neoadjuvant therapy with adebrelimab plus nab-paclitaxel and cisplatin for three cycles. All three cycles of immunotherapy plus chemotherapy are initiated at or after 15:00.
Receives: Drug: Adebrelimab plus nab-paclitaxel and cisplatin

What is being measured

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

  1. Pathological complete response rate (pCR)

    Measured: Pathological detection after surgery within 1 month

Secondary outcomes (3)

  1. Major pathological response rate (MPR)

    Measured: Pathological detection after surgery within 1 month

  2. Event-free survival (EFS)

    Measured: from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 60 months)

  3. Overall survival（OS）

    Measured: from randomization to death from any cause，assessed up to 60 months

Timeline

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

  1. First posted5 Mar 2026
  2. Study start5 May 2026
  3. Primary completion25 Feb 2027 (estimated)
  4. Study completion30 Dec 2028 (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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452601
Sponsor's protocol ID
IIT20260122
Status last verified
May 2026
First submitted
28 Feb 2026
Last updated
28 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 plus nab-paclitaxel and cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Tang-Du Hospital 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 15 inclusion and 20 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 28 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR) (time frame: Pathological detection after surgery within 1 month). 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 NCT07452601.

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 28 May 2026.

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