Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC)

NCT06420908 | Withdrawn

• 1 other identifier: ARL-ESCC-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Baseline to measured date of progression or death from any cause

  evaluated in 24 months since the treatment began

Secondary Outcomes (4)

• 1. Objective response rate (ORR)

  tumor assessment every 6 weeks since the treatment began，up to 24 monthss

• 2. Duration of Overall Response（DoR）

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• 3. Overall survival (OS)

  the first day of treatment to death or last survival confirm date,up to 24 months

• 4. Adverse events

  up to 24 months

Study Arms (2)

PET-CT responders

EXPERIMENTAL

SUV (PETr) reduction \>35%

Drug: Adebrelimab+TP/FP+ radiation therapy

PET-CT non-responders

EXPERIMENTAL

SUV (PETr) reduction ≤35%

Drug: Adebrelimab+FP/TP+ radiation therapy

Interventions

Adebrelimab+TP/FP+ radiation therapy DRUG

Induction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs.

PET-CT responders

Adebrelimab+FP/TP+ radiation therapy DRUG

Induction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: (switch to a different chemotherapy drug which not used during the earlier induction phase) FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs.

PET-CT non-responders

Eligibility Criteria

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

You may qualify if:

• Blood routine examination:
• HB≥90g/L;
• ANC ≥ 1.5 × 109 / L;
• PLT ≥ 100 × 109 / L;
• Biochemical examination:
• ALT and AST \< 2.5×ULN;
• TBIL ≤ 1.5×ULN;
• Cr ≤ 1.5×ULN; 9. Left ventricular ejection fraction (LVEF) ≥50%; 11. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 12. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

You may not qualify if:

• Previous history of esophageal cancer surgery；
• Higher risk of esophageal perforation or fistula；
• Received systemic immunosuppressive therapy within 14 days prior to the first study medication；
• Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function;
• 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);
• 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)；
• Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur;
• 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;
• 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;
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• History of psychiatric drugs abuse and can't quit or patients with mental disorders;
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08