Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaPhase 2NCT07112833

A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)

A Phase 2 study testing Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab in people with Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital 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 study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT or RECIST1.1 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
What is being tested?: Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteChina
Study dates: 10 Aug 2025to 31 Dec 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

1. Age 18-75 years old, both men and women; 2. Histopathology confirmed esophageal squamous cell carcinoma, locally advanced: T1N+M0, T2-4bNxM0; 3. The surgeon assesses that surgery is not feasible or the patient refuses surgical treatment; 4. If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 5. Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 6. Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 7. At least one measurable lesion（According to RECIST 1.1：The long diameter of the measurable lesion on CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm）; 8. ECOG: 0~1; 9. Expected survival period ≥ 12 weeks; 10. Major organ function has to meet the following certeria: (1) Blood routine examination: 1. HB≥90g/L; 2. ANC ≥ 1.5 × 109 / L; 3. PLT ≥ 100 × 109 / L; (2) Biochemical examination: a. ALT and AST < 2.5XULN; b. TBIL ≤ 1.5XULN; c. Cr ≤ 1.5XULN; 11. Left ventricular ejection fraction (LVEF) ≥50%; 12. Female subjects of childbearing age or male who undergo non-surgical sterilization must agree to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pill) for contraception during the study treatment period and within 3 months after the end of the study treatment period. For female subjects of childbearing age who undergo non-surgical sterilization, the serum HCG test must be negative within 7 days before the first administration. 13. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Who cannot join

1. Previous history of esophageal cancer surgery； 2. Higher risk of esophageal perforation or fistula； 3. Received systemic immunosuppressive therapy within 14 days prior to the first study medication； 4. Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function; 5. The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 6. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)； 7. Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur; 8. History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention; 9. Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate.

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

The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jun Wang, 13931182128, wangjunzr@163.com
Jun Wang

Other trials in China

About this study

Conditions: Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Being tested: Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab

What participants receive

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

Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: AdebrelimabDrug
Induction stage：Adebrelimab+TC： Adebrelimab : 1200mg d1, iv, q3w ； TC : paclitaxel 135mg/m2, or nab-paclitaxel paclitaxel 180mg/m2, d1, iv，carboplatin AUC=5, d1, iv, q3w，2 cycles.
Treatment stage: TC/PF+ radiation therapy:
PET-CT responders (SUV (PETr) reduction ≥35%)：
TC/PF+ radiation therapy:
TC : paclitaxel 50mg/m2, nab-paclitaxel paclitaxel 60mg/m2, d1, iv; carboplatin AUC=2, d1, iv, qw，5 cycles.
PF : fluorouracil 750-1000mg/m2, CIV 96 hours，cisplatin 75mg/m2, d1, iv, q4w，2 cycles.
Radiation therapy: 50.4Gy-60Gy/28-33f.
PET-CT non-responders (SUV (PETr) reduction <35%)：(switch to a different chemotherapy drug which not used during the earlier induction phase)
PF/TC+ radiation therapy:
dose same as above.
Maintenance stage: Adebrelimab:
Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs（Up to one year）.

Study groups in NCT07112833
Study group	Role	What they receive
Experimental	Experimental	Induction stage：Adebrelimab+TC； Treatment stage: TC/PF+ radiation therapy； Maintenance stage: Adebrelimab Receives: Drug: Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab

What is being measured

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

1-year Progression-Free-Survival (PFS) rate
PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
Measured: 12 months

Secondary outcomes (7)

cCR rate
A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.
Measured: 12 months
Objective Response Rate, ORR
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: 12 months
Disease Control Rate, DCR
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Measured: 12 months
Duration of Response, DoR
Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.
Measured: 12 months
Progression free Survival, PFS
PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.
Measured: 24 months
Overall survival, OS
Defined as the time between signing the informed consent form to death due to various causes.
Measured: 24 months
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading.
Measured: 24 months

Timeline

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

10 Aug 202531 Dec 2027

First posted8 Aug 2025
Study start10 Aug 2025 (estimated)
Primary completion10 Aug 2025 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced Unresectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07112833
Sponsor's protocol ID: MA-EC-II-024
Status last verified: Aug 2025
First submitted: 1 Aug 2025
Last updated: 8 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1/2
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 3
Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunotherapy Induction Plus CCRT: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study
Esophageal Squamous Cell Carcinoma (ESCC)

All Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Clinical Study of Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)
ClinicalTrials.gov ID: NCT07112833
Acronym / sponsor ID: MA-EC-II-024
Conditions: Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 36 participants (estimated)
Lead sponsor: Hebei Medical University Fourth HospitalUniversity, hospital or other
Study start: 10 Aug 2025 (estimated)
Primary completion: 10 Aug 2025 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 8 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Drug: Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: AdebrelimabInduction stage：Adebrelimab+TC； Treatment stage: TC/PF+ radiation therapy； Maintenance stage: Adebrelimab

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Age 18-75 years old, both men and women; 2. Histopathology confirmed esophageal squamous cell carcinoma, locally advanced: T1N+M0, T2-4bNxM0; 3. The surgeon assesses that surgery is not feasible or the patient refuses surgical treatment; 4. If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 5. Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 6. Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 7. At least one measurable lesion（According to RECIST 1.1：The long diameter of the measurable lesion on CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm）; 8. ECOG: 0~1; 9. Expected survival period ≥ 12 weeks; 10. Major organ function has to meet the following certeria: (1) Blood routine examination: 1. HB≥90g/L; 2. ANC ≥ 1.5 × 109 / L; 3. PLT ≥ 100 × 109 / L; (2) Biochemical examination: a. ALT and AST < 2.5XULN; b. TBIL ≤ 1.5XULN; c. Cr ≤ 1.5XULN; 11. Left ventricular ejection fraction (LVEF) ≥50%; 12. Female subjects of childbearing age or male who undergo non-surgical sterilization must agree to use at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pill) for contraception during the study treatment period and within 3 months after the end of the study treatment period. For female subjects of childbearing age who undergo non-surgical sterilization, the serum HCG test must be negative within 7 days before the first administration. 13. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Key exclusion criteria (1 listed)

1. Previous history of esophageal cancer surgery； 2. Higher risk of esophageal perforation or fistula； 3. Received systemic immunosuppressive therapy within 14 days prior to the first study medication； 4. Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function; 5. The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 6. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)； 7. Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur; 8. History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention; 9. Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: AdebrelimabInduction stage：Adebrelimab+TC： Adebrelimab : 1200mg d1, iv, q3w ； TC : paclitaxel 135mg/m2, or nab-paclitaxel paclitaxel 180mg/m2, d1, iv，carboplatin AUC=5, d1, iv, q3w，2 cycles. Treatment stage: TC/PF+ radiation therapy: PET-CT responders (SUV (PETr) reduction ≥35%)： TC/PF+ radiation therapy: TC : paclitaxel 50mg/m2, nab-paclitaxel paclitaxel 60mg/m2, d1, iv; carboplatin AUC=2, d1, iv, qw，5 cycles. PF : fluorouracil 750-1000mg/m2, CIV 96 hours，cisplatin 75mg/m2, d1, iv, q4w，2 cycles. Radiation therapy: 50.4Gy-60Gy/28-33f. PET-CT non-responders (SUV (PETr) reduction <35%)：(switch to a different chemotherapy drug which not used during the earlier induction phase) PF/TC+ radiation therapy: dose same as above. Maintenance stage: Adebrelimab: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs（Up to one year）.	Drug	Experimental

Primary outcome

1-year Progression-Free-Survival (PFS) rate
Time frame: 12 months
PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

7 secondary outcomes

cCR rate
Time frame: 12 months
Objective Response Rate, ORR
Time frame: 12 months
Disease Control Rate, DCR
Time frame: 12 months
Duration of Response, DoR
Time frame: 12 months
Progression free Survival, PFS
Time frame: 24 months
Overall survival, OS
Time frame: 24 months
Incidence of adverse events
Time frame: 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.

Related trials for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 1/2
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 3
Stratified Treatment in Unresectable Locally Advanced ESCC Without Progression After Chemoimmunotherapy Induction Plus CCRT: Toripalimab Consolidation vs observation--a Prospective, Randomized, Controlled Phase III Multicenter Study
Esophageal Squamous Cell Carcinoma (ESCC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

13931182128

wangjunzr@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 8 Aug 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?

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?

1-year Progression-Free-Survival (PFS) rate (time frame: 12 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 NCT07112833.

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 8 Aug 2025.