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

NCT ID: NCT07112833

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-10
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Induction stage：Adebrelimab+TC； Treatment stage: TC/PF+ radiation therapy； Maintenance stage: Adebrelimab

Group Type: EXPERIMENTAL

Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab

Intervention Type: DRUG

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）.

Interventions

Induction stage：Adebrelimab+TC；Treatment stage: TC/PF+ radiation therapy；Maintenance stage: Adebrelimab

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）.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun wang

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Facility Contacts

Jun Wang

Role: primary

wangjunzr@163.com

13931182128

Other Identifiers

MA-EC-II-024

Identifier Type: -

Identifier Source: org_study_id