Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer

Sponsor
The Affiliated Hospital of Putian University
Study ID
NCT07780721
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab: 1200 mg, intravenous infusion on Day 1, every 3 weeks (Q3W)
  • Thymalfasin — DRUG
    Thymalfasin: 1.6 mg, subcutaneous injection twice weekly for every 3-week cycle.
  • Chemotherapy — DRUG
    Nab-paclitaxel: 260 mg/m², intravenous infusion on Day 1, every 3 weeks (Q3W); Cisplatin: 75 mg/m², intravenous infusion on Day 1 / Day 2 / Day 3, every 3 weeks (Q3W); OR Carboplatin: AUC = 5-6, intravenous infusion on Day 1, every 3 weeks (Q3W).

Study Details

This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.

Key Dates

First listed
Aug 21, 2026
Start date
Aug 30, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm (Adebrelimab + Thymalfasin + Chemotherapy Neoadjuvant Regimen)
    All eligible patients receive neoadjuvant therapy for 2-3 cycles (3 weeks per cycle), followed by radical esophagectomy with lymph node dissection.

Primary Outcome Measure

Pathologic Complete Response (pCR) Rate [ Time Frame: 2 weeks after surgery ]

Central Contacts

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