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Esophageal CancerPhase 2NCT06452602

Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.

A Phase 2 study testing Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy and Induction immunochemotherapy followed by concurrent chemoradiotherapy in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and 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 trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy and Induction immunochemotherapy followed by concurrent chemoradiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
19 Jun 2024to 1 Jun 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

  • Volunteered to participate, cooperated with follow-up visits;
  • Aged 18 years or older, both male and female;
  • Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );
  • Clinically staged as II-IVb inoperable locally advanced ESCC(including non-resectable, or with contraindications to or refusal of surgery);
  • ECOG performance status 0 or 1;
  • Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;
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  • Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
  • Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded [FFPE] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
  • Expected survival ≥ 3 months;
  • Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l;
  • Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels >1.5× ULN (Calculated from the Cockcroft-Gault formula);
  • Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl;
  • Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;
  • Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.
  • Documented informed consent.

Who cannot join

  • Surgery for esophageal cancer;
  • Esophageal fistulae due to infiltration of the primary tumour;
  • Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
  • Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
  • Major surgery or severe trauma within 4 weeks prior to first use of study drug;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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  • Received or receiving any of the following treatments in the past:
  • Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
  • Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
  • Systemic treatment with corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
  • Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
  • Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
  • Diagnosis of immunodeficiency, including positive HIV test,other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
  • Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Severe infections (CTCAE > Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;
  • History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
  • Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
  • Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);
  • Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;
  • Known hypersensitivity to large protein preparations, or to any of the components of nab-paclitaxel or carboplatin or to any of the components used within their preparations;
  • Pregnant or lactating patients.

Trial locations and contacts

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

Wencheng zhang, M.D. contact

02223340123 ext. 1121

zhangwencheng@tjmuch.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Wen Cheng, M.D., 02223340123 ext. 1121, zhangwencheng@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Stratified Exploratory Phase 2 Trial.

This trial is conducted in patients with unresectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 60 patients with unresectable locally advanced esophageal cancer in Tianjin cancer hospital.

After 2 cycles of induction immunochemotherapy, 60 patients with ESCC will be divided into 2 groups (CR+PR group and SD+PD group) according to the efficacy of induction therapy. Patients in the CR+PR group will be treated with the same immunochemotherapy regimen plus concurrent radiotherapy (50.4Gy/1.8Gy/28f) . And immunotherapy will maintain for a maximum of 1 year. Patients in the SD+PD group will be treated with concurrent chemoradiotherapy (Radiotherapy: PTV/PGTV:50.4Gy/59.92Gy/28f and another chemotherapy regimen). Immunotherapy will not used during chemoradiotherapy because of immunotherapy resistance.

The trial can effectively stratify patients by induction immunochemotherapy, and a more appropriate treatment regimen for patients has the potential to further improve PFS and prolong OS in all patients.

Being tested
Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy, Induction immunochemotherapy followed by concurrent chemoradiotherapy
Keywords
Induction Immunochemotherapy, Adebrelimab, Esophageal Squamous Cell Carcinoma
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapyDrug

    Also called Adebrelimab plus concurrent chemoradiotherapy, CR+PR group

    Induction immunochemotherapy:

    Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22.

    Evaluation of the Curative Effect：CR+PR

    Adebrelimab plus concurrent chemoradiotherapy:

    Adebrelimab：1200mg, IV，q3w, until PD; Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f.

  • Induction immunochemotherapy followed by concurrent chemoradiotherapyDrug

    Also called Concurrent chemoradiotherapy, SD+PD group

    Induction immunochemotherapy:

    Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22.

    Evaluation of the Curative Effect：SD+PD

    Concurrent chemoradiotherapy:

    Oxaliplatin：85 mg/m2，IV，d1，d15，d29; Leucovorin：400mg/m2，IV，d1，d15，d29; 5-FU：400mg/m2，IV，d1，d15，d29; 5-FU：1600mg/m2，CIV48h，d1，d15，d29; Radiotherapy：PTV/PGTV:50.4Gy/59.92Gy/28f.

Study groups in NCT06452602
Study groupRoleWhat they receive
Induction ImmunochemotherapyExperimentalNot described
Receives: Drug: Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy; Drug: Induction immunochemotherapy followed by concurrent chemoradiotherapy

What is being measured

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

  1. PFS

    progression-free survival

    Measured: up to 2 years

Secondary outcomes (4)

  1. OS

    overall survival

    Measured: up to 2 years

  2. ORR

    overall response rate

    Measured: up to 2 years

  3. DoR

    Duration of Response

    Measured: up to 2 years

  4. AE

    Adverse events

    Measured: up to 3 years

Timeline

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

  1. First posted11 Jun 2024
  2. Study start19 Jun 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2027 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452602
Sponsor's protocol ID
E20240610
Status last verified
Jun 2025
First submitted
5 Jun 2024
Last updated
27 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tang P, Gao L, Zuo S, Zhang K, Wang T, Zheng J, Chen X, Dong J, Pang Q, Wang P, Zhang W, Zhang T. Adebrelimab plus chemotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma (ESCC): a single-center, phase II, single-arm, open-label clinical trial (ADENEO) protocol. BMC Cancer. 2026 Mar 13;26(1):504. doi: 10.1186/s12885-026-15850-5.

    PubMed 41820935

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction immunochemotherapy followed by Adebrelimab plus concurrent chemoradiotherapy and Induction immunochemotherapy followed by concurrent chemoradiotherapy in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and 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 21 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 27 Feb 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 Wencheng zhang, M.D. (02223340123 ext. 1121, zhangwencheng@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: up to 2 years). 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 NCT06452602, which also lists 1 linked publication.

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 27 Feb 2026.

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