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

NCT07112833 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-EC-II-024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (7)

• cCR rate

  12 months

• Objective Response Rate, ORR

  12 months

• Disease Control Rate, DCR

  12 months

• Duration of Response, DoR

  12 months

• Progression free Survival, PFS

  24 months

Study Arms (1)

Experimental

EXPERIMENTAL

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

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

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: August 10, 2025
• Primary Completion: August 10, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)