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

NCT ID: NCT06420908

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2027-05-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PET-CT responders

SUV (PETr) reduction \>35%

Group Type: EXPERIMENTAL

Adebrelimab+TP/FP+ radiation therapy

Intervention Type: 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 non-responders

SUV (PETr) reduction ≤35%

Group Type: EXPERIMENTAL

Adebrelimab+FP/TP+ radiation therapy

Intervention Type: 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.

Interventions

Adebrelimab+TP/FP+ radiation therapy

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.

Intervention Type: DRUG

Adebrelimab+FP/TP+ radiation therapy

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Blood routine examination:

1. HB≥90g/L;

2. ANC ≥ 1.5 × 109 / L;

3. PLT ≥ 100 × 109 / L;

2. Biochemical examination:

1. ALT and AST < 2.5×ULN;

2. TBIL ≤ 1.5×ULN;

3. 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.

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

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ARL-ESCC-001

Identifier Type: -

Identifier Source: org_study_id