Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Putian University

About this trial

This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provided written informed consent and voluntarily enrolled in this study;

Aged 18-75 years, male or female;

Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC);

Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;

Disqualifiers

Significant tumor invasion into adjacent organs of the esophageal lesion (e.g., major arteries or trachea);

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;

Poor nutritional status with a Body Mass Index <18.5 kg/m² (BMI <18.5 kg/m²); subjects whose BMI is corrected with targeted nutritional support prior to randomization may be considered for enrollment at the discretion of the principal investigator;

History of hypersensitivity to monoclonal antibodies, any component of adebrelimab, paclitaxel, cisplatin, or other platinum-based agents;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Adebrelimab 1200 mg or 20 mg/kg, intravenous infusion, every 3 weeks (Q3W);

  • chemotherapy

    Drug

    nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) 100 mg/m² on Days 1 and 8 (D1/D8), intravenous infusion, every 3 weeks (Q3W); Cisplatin 75 mg/m² on Days 1, 2 and 3 (D1/D2/D3), intravenous infusion, every 3 weeks (Q3W).

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Adebrelimab in combination chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response Rate (pCR)

Time frame
Four weeks after surgery

Secondary outcomes

1

Surgical R0 resection rate

Time frame
Four weeks after surgery
2

Main pathological relief (MPR)

Time frame
Four weeks after surgery
3

Disease-Free Survival (DFS)

Time frame
24-months
4

Objective Response Rate (ORR)

Time frame
Up to 3 months per two cycles (21 days per cycle)]

Other outcomes

Sponsors and contacts

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