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A Single-arm Exploratory Study of Adebrelimab Combined With Famitinib and Chemotherapy as Neoadjuvant Treatment for Thoracic Esophageal Squamous Cell Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, single-arm, exploratory clinical study enrolling patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma (ESCC) confirmed by histology or cytology. The study aims to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab in combination with famitinib and chemotherapy in this population. The primary endpoint is the pathological complete response (pCR) rate, with a planned enrollment of 24 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Signed written informed consent and voluntarily agrees to participate in the study.

• Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).

• Thoracic esophageal cancer evaluated by CT, MRI, or EUS, with clinical stage T1b-T2N+ or T3-T4a, any N (according to the AJCC 8th edition).

• Expected to achieve R0 resection after neoadjuvant therapy.

• Age between 18 and 75 years, male or female.

• \*\*ECOG performance status of 0-1.

• No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, or surgery.

• Planned to undergo surgical resection after completion of neoadjuvant therapy.

• No contraindications to surgery.

⁃ Adequate organ function, defined as follows:

⁃ a) Hematology (without the use of any blood components, hematopoietic growth factors, leukocyte or platelet stimulants, or anemia-correcting agents within 14 days before first study drug administration):

⁃ \* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L

⁃ \* Platelet count ≥ 100 × 10⁹/L

‣ Hemoglobin ≥ 90 g/L b) Serum biochemistry:

‣ Total bilirubin ≤ 1.5 × ULN

‣ ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN

‣ Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min c) Coagulation:

‣ INR ≤ 1.5 × ULN

‣ APTT ≤ 1.5 × ULN

⁃ Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to first dosing and must agree to use effective contraception (such as intrauterine device, oral contraceptives, or condoms) during the study and for at least 3 months after the last dose.Male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose.

⁃ Good compliance and willingness to adhere to study visits and follow-up requirements.

Locations
Other Locations
China
First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Yong Zhang, Dr
thouderous@163.com
17795600105
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 24
Treatments
Experimental: Adebrelimab + Famitinib + Chemotherapy
Preoperative (Neoadjuvant) Treatment:~Each treatment cycle lasts 3 weeks (Q3W), for a total of 2 cycles. Adebrelimab 1200 mg, intravenous infusion on Day 1, Q3W Paclitaxel 175 mg/m², intravenous infusion on Day 1, Q3W Cisplatin 75 mg/m², intravenous infusion on Day 1, Q3W Drugs are administered in the following order with at least a 30-minute interval between infusions: Adebrelimab → Paclitaxel → Cisplatin.~Famitinib 10 mg orally once daily (po, qd), administered 30 minutes after a meal, for 2 weeks on followed by 1 week off (Q3W).
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital Xi'an Jiaotong University

This content was sourced from clinicaltrials.gov

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