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Esophageal Squamous Cell CarcinomaPhase 2NCT06861894

Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC

A Phase 2 study testing Adebrelimab and nab-paclitaxel and carboplatin, Radiation and standard oesophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Zhigang Li 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

In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with… 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 and nab-paclitaxel and carboplatin, Radiation and standard oesophagectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteChina
Study dates
Jul 2025to Mar 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

  • Subjects signed the informed consent and volunteered to participate in the study.
  • Esophageal squamous cell carcinoma confirmed by histology or cytology.
  • Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
  • Expect to have R0 resection
  • In age from 18 to 75.
  • ECOG PS: 0~1.
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  • Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
  • No contraindications to surgery.
  • Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN
  • Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.
  • Good compliance, willing to comply with follow-up schedules.

Who cannot join

  • Subjects have received or are receiving any of:
  • anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.
  • immunosuppressants or systemic glucosteroids (prednisone equivalence> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence>10mg/d) is allowed if no known active autoimmune disease.
  • live vaccine within 4 weeks before the first administration.
  • major surgery or major injury within 4 weeks before the first administration.
  • Cancer-related exclusion criteria
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  • other cancers instead of ESCC
  • unresectable or metastatic ESCC
  • not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）
  • Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)
  • Other criteria
  • Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia that needs treatment
  • Subjects with any known active autoimmune disease
  • Pregnant or breastfeeding female
  • Presence of allergy or hypersensitivity to investigational medications
  • HIV-positive or active hepatitis B (HBsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis
  • Investigators assessed there might be other factors that cause subjects to withdraw.

Trial locations and contacts

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

Zhigang Li, MD, PhD contact

86-18960619260

zhigang.li@shsmu.edu.com

Zhichao Liu, MD, PhD contact

86-15622175948

zhichao.liu@sjtu.edu.cn

China1 site

  • Shanghai Chest Hospital

    Shanghai

    Zhigang Li, MD, PhD, 18960619260, zhigang.li@shsmu.edu.com

Other trials in China

About this study

Official title: Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma

In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.

Being tested
Adebrelimab and nab-paclitaxel and carboplatin, Radiation, standard oesophagectomy, active surveillance
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 and carboplatinDrug

    Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy

  • RadiationRadiation

    concurrent chemoradiotherapy

  • standard oesophagectomyProcedure or surgery

    standard oesophagectomy

  • active surveillanceOther

    active surveillance

Study groups in NCT06861894
Study groupRoleWhat they receive
perioperative treatment with adebrelimab and CRTExperimentalNot described
Receives: Drug: Adebrelimab and nab-paclitaxel and carboplatin; Radiation: Radiation; Procedure: standard oesophagectomy; Other: active surveillance

What is being measured

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

  1. 2-year OS rate

    An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.

    Measured: 24 months

Secondary outcomes (6)

  1. cCR rate

    A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.

    Measured: 12 months

  2. median EFS

    An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first.

    Measured: 24 months

  3. median OS

    An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.

    Measured: 24 months

  4. Incidence, type and severity of adverse events as assessed by CTCAE 5.0

    Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 adverse events and higher-grade will be reported.

    Measured: 24 months

  5. quality of life (QOL)

    Evaluate quality of life using EORTC QLQ-C30

    Measured: 24 months

  6. quality of life (QOL) assessed by EORTC QLQ-OES18

    Evaluate quality of life using EORTC QLQ-OES18

    Measured: 24 months

Timeline

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

  1. First posted6 Mar 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 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
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06861894
Sponsor's protocol ID
MA-EC-II-017
Status last verified
Mar 2025
First submitted
3 Mar 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab and nab-paclitaxel and carboplatin, Radiation and standard oesophagectomy in people with Esophageal Squamous Cell Carcinoma, run by Zhigang Li 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 11 inclusion and 17 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 15 May 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 Zhigang Li, MD, PhD (86-18960619260, zhigang.li@shsmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year OS rate (time frame: 24 months). 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 NCT06861894.

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 15 May 2025.

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